1 Apr 2026 Benjamin Daniel Rowley · Prevention of Future Deaths report Greater Lincolnshire
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Concerns raised 1 Failure of the permanent bond between CVC venous ports and silicone rubber tubing View source
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AI-generated summary
Benjamin Daniel Rowley · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
On 7 November 2025, Benjamin Daniel Rowley attended dialysis when a connector on his central venous catheter disconnected, causing blood loss. He was taken to hospital, where his death was later confirmed; the stated clinical cause included haemorrhage from the catheter port. The investigation raised concerns about mechanical failure of the catheter and a possible wider vulnerability affecting this brand or dialysis lines.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of the permanent bond between CVC venous ports and silicone rubber tubing
Wider context from the report ““The CVC consists of a number of parts that are assembled during the manufacturing process. The two ports consist of a brown and a blue plastic Luer Lock connector permanently bonded to silicone rubber tubes that enter the ‘Y’ shaped connector. A white plastic sleeve is present at the point the ports enter the rubber tubing. These ports are not intended to ever be removed or detached from the silicone rubber tubes. The integrity of the permanent bond between the ports and the tubing is essential for the safety of the CVC.
[Mr Rowley] died due to exsanguination caused by a mechanical failure of the CVC. The direct cause was failure of the bond between the venous port of the CVC and the tubing, allowing the port to detach thereby causing blood returning from the machine to the patient to be expelled.”
In relation to the later incident of 11 December 2025, the relevant section of the preliminary report states:
“The nature of the failure of this CVC appears to be identical to that of Mr Rowley, namely detachment of one port of the CVC from the silicone rubber tube.
The direct cause was failure of the bond between the venous port of the CVC and the tubing, allowing the port to detach thereby causing blood returning from the machine to the patient to be expelled. The nature of the failure appears identical...”
The report concludes that:
“I am concerned that these events could represent a more widespread vulnerability of this brand or of dialysis lines and recommend reporting these events to the Medicines and Healthcare products Regulatory Agency (MHRA).”
I endorse those concerns.
” Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review the manufacturer’s investigation and available safety data for evidence of a wider catheter detachment or bonding-failure trend.
Verbatim wording from the response “Review of the available UK data within the MHRA’s safety database did not identify additional reports that would indicate a wider potential safety concern. This is reflected in the legal manufacturer’s data, particularly when accounting for global use and sales. The MHRA has also reviewed the accompanying Instructions For Use (IFU) and determined that whilst the documents are in line with the legal requirements, improvements can be made to provide users with guidance on catheter line durability, maintenance and repair. The MHRA is working with the manufacturer in addressing this.” Source location Response from Medicines and Healthcare Products Regulatory Agency
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Put measures in place to increase monitoring of events involving Covidien Palindrome Chronic Dual Lumen Catheters through vigilance activities.
Verbatim wording from the response “• The MHRA has put in place measures to increase monitoring of events related to Covidien Palindrome Chronic Dual Lumen Catheters and will continue to review these as part of our vigilance activities. Any further regulatory actions required following this will be communicated via the usual routes.” Source location Response from Medicines and Healthcare Products Regulatory Agency
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Obtain routine updates from the manufacturer on UK and global reports of venous-port detachment and mechanical bond failure while its investigation continues.
Verbatim wording from the response “• The MHRA has reviewed the investigation undertaken by Mozarc Medical in response to these two events of venous port detachment. Based on the limited number of UK and global reports, there does not appear to be a batch or device trend indicating a wider issue with a failure in bonding of components of this catheter type observed at this time. No root cause has been identified by the company based on their product and manufacturing analysis. The MHRA has asked Mozarc Medical to provide routine updates on the number of UK and global reports concerning venous port detachment and mechanical bond failure, whilst this investigation is ongoing. This is in addition to their routine post-marketing surveillance requirements.” Source location Response from Medicines and Healthcare Products Regulatory Agency
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Available UK and global data do not indicate a batch or device trend showing a wider bonding failure issue at this time.
Verbatim wording from the response “• The MHRA has reviewed the investigation undertaken by Mozarc Medical in response to these two events of venous port detachment. Based on the limited number of UK and global reports, there does not appear to be a batch or device trend indicating a wider issue with a failure in bonding of components of this catheter type observed at this time. No root cause has been identified by the company based on their product and manufacturing analysis. The MHRA has asked Mozarc Medical to provide routine updates on the number of UK and global reports concerning venous port detachment and mechanical bond failure, whilst this investigation is ongoing. This is in addition to their routine post-marketing surveillance requirements.” Source location Response from Medicines and Healthcare Products Regulatory Agency
Open published response
22 Jan 2026 Clive Mark Hyman · Prevention of Future Deaths report Inner North London
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Concerns raised 1 Lack of patient information on actions after head trauma during apixaban treatment View source
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AI-generated summary
Clive Mark Hyman · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Clive Mark Hyman, who was taking apixaban, fell and hit his head on 1 August 2025 but did not seek medical advice because he felt well. He later developed a sudden severe headache, became unresponsive, and was found to have a subdural haemorrhage and extensive brain injury; he died in hospital on 10 August 2025. The concerns relate to guidance for people taking apixaban after head trauma, including the absence of clear advice in reviewed patient leaflets to seek medical attention after such an injury.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of patient information on actions after head trauma during apixaban treatment
Wider context from the report “1) NICE guidelines NG232 on the Assessment and Early Management of Head Injury state at paragraph 1.2.1 “Public health literature and other non-medical sources of advice ... should encourage people who have any concerns after a head injury ... to seek immediate medical advice. Paragraphs 1.2.3 and 1.2.4 of the guidance state that remote advice services and community health services “should refer people who have sustained a head injury to a hospital emergency department ... if there are any of these risk factors ... current anticoagulant or antiplatelet (except aspirin monotherapy) treatment”
2) Having reviewed several patient information leaflets issued with apixaban, it is evident that patients are routinely advised not to take the drug if they are “bleeding excessively”. In addition, they are advised to seek medical advice if they are at “increased risk of bleeding”. None of the patient information leaflets that I reviewed expressly addressed the steps to be taken by a patient if they sustain trauma to the head.
3) Patients who have experienced head trauma may not realise that they have sustained an intracranial bleed. As head injuries can be asymptomatic for some time following trauma, apixaban users may continue taking the medication and avoid seeking medical advice because they feel well. As a result of taking apixaban, bleeding may continue. By the time symptoms of a brain injury emerge (e.g. a sudden, severe headache) the patient may be critically ill and have a reduced potential for recovery.
” Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Conduct a full review of patient information for all direct oral anticoagulants, including apixaban, and warfarin.
Verbatim wording from the response “To date we have completed a preliminary assessment of the issue, which was also discussed at an internal multidisciplinary Review Meeting. We can confirm that a full review, across all Direct Oral Anticoagulants (DOACs; including apixaban) and warfarin, is now underway. Once finalised we will seek expert advice regarding any potential updates to product information.” Source location Response from Medicines & Healthcare products Regulatory Agency
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Complete a preliminary assessment of head-trauma warnings for patients taking anticoagulants and discuss the issue at an internal multidisciplinary review meeting.
Verbatim wording from the response “To date we have completed a preliminary assessment of the issue, which was also discussed at an internal multidisciplinary Review Meeting. We can confirm that a full review, across all Direct Oral Anticoagulants (DOACs; including apixaban) and warfarin, is now underway. Once finalised we will seek expert advice regarding any potential updates to product information.” Source location Response from Medicines & Healthcare products Regulatory Agency
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Seek expert advice on potential updates to anticoagulant product information after finalising the full review.
Verbatim wording from the response “To date we have completed a preliminary assessment of the issue, which was also discussed at an internal multidisciplinary Review Meeting. We can confirm that a full review, across all Direct Oral Anticoagulants (DOACs; including apixaban) and warfarin, is now underway. Once finalised we will seek expert advice regarding any potential updates to product information.” Source location Response from Medicines & Healthcare products Regulatory Agency
Open published response
11 Dec 2025 Mrs Ashana Charles · Prevention of Future Deaths report South London
View report summary
Concerns raised 8 Lack of assurance that PN and filter manufacturers issue consistent guidance and operationally consistent products View source Failure to establish adequate safety assurance from visual checks of PN products View source Failure of drug manufacturer guidance to specify the need, desirability or context of filter use for Omega Special View source Failure to submit 1.2 micron filter use for governance oversight View source Failure to retain infusion equipment and supplies for forensic investigation View source Inconsistency between regional guidance on use of filters in parenteral feeding View source Inadequate investigation of deaths potentially associated with IV feeding View source Failure to use 1.2 micron filters as standard practice in parenteral feeding View source See 5 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
Mrs Ashana Charles · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Mrs Ashana Charles died suddenly in hospital on 20 November 2018 after an unexpected cardiac arrest during intravenous feeding. The inquest concluded that cellulose fibres from inadvertently contaminated intravenous infusions caused acute obstruction of small pulmonary arteries, and that the death would have been prevented by using a 1.2-micron filter, which was not standard practice at the time. Concerns included the failure to retain infusion equipment for forensic investigation, inconsistent guidance and practice on filters, and uncertainty about the adequacy of batch-based visual checks of parenteral nutrition products.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of assurance that PN and filter manufacturers issue consistent guidance and operationally consistent products
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation.
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN).
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance .
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to establish adequate safety assurance from visual checks of PN products
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation.
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN).
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance.
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of drug manufacturer guidance to specify the need, desirability or context of filter use for Omega Special
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation.
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN).
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use , and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance.
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to submit 1.2 micron filter use for governance oversight
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation.
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN).
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance.
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to retain infusion equipment and supplies for forensic investigation
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation . The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation.
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN).
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance.
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inconsistency between regional guidance on use of filters in parenteral feeding
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation.
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN) .
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance.
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate investigation of deaths potentially associated with IV feeding
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation .
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN).
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance.
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to use 1.2 micron filters as standard practice in parenteral feeding
Wider context from the report “1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation.
2. ████████, expert pharmacist and pharmaceutical regulator drew attention to
a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN).
b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management.
c) The use of the 1.2 micron filter at the time was not standard practice , perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance.
d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies.
e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance.
” Open source report
14 Oct 2025 Paula Doreen Hughes · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 7 Failure to prevent concurrent prescriptions of paracetamol-containing drugs View source Lack of robust mechanisms to mitigate confirmation bias and encourage professional curiosity View source Lack of a mechanism for consistently recording pre-admission over-the-counter medications View source Insufficient guidance for accurate and consistent assessment of the ACVPU confusion element View source Lack of guidance or policy for deciding when virtual reviews can replace face-to-face reviews View source Lack of a robust process for managing therapeutic excess and potential toxicity View source Risk of loss or dilution of prescribing safety nets during electronic system changes View source See 4 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Paula Doreen Hughes · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Paula Doreen Hughes was admitted to hospital after a fall and received paracetamol in excess of the recommended dose because paracetamol was prescribed alongside co-codamol. The overdose was not recognised until she had developed fulminant acute liver failure, and timely treatment was not provided. The principal concerns included preventing duplicate paracetamol prescriptions and administration, recognising and managing therapeutic excess, accurately assessing confusion, recording over-the-counter medicines, mitigating confirmation bias, and providing guidance for virtual patient reviews.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to prevent concurrent prescriptions of paracetamol-containing drugs
Wider context from the report “1. In respect of preventing concurrent prescriptions of paracetamol containing drugs and otherwise preventing prescribing errors resulting in therapeutic excess of paracetamol (NHSE, RPS, Cerner, MHRA, LGT)
(1) NHSE, RPS, Cerner, MHRA
I consider that the risk of concurrent prescriptions of paracetamol containing drugs is of wider national concern.
The Cerner prescribing system offers a duplicate checking functionality that is not a standard feature. It is hard stop and can be overridden and was not adopted by the LGT when the system was introduced. All the healthcare professionals were aware that co-codamol contained paracetamol and should not be prescribed with paracetamol. However, the 2 prescribing doctors failed to recognise that Mrs Hughes was already prescribed a paracetamol containing drug. 2 nurses failed to recognise they were administering 2 paracetamol containing drugs. A pharmacist failed to identify the concurrent prescriptions during reconciliation.
(2) LGT
LGT’s response to the incident was swift and commendable. A hard stop was introduced to the electronic prescribing system which eliminated concurrent prescriptions of paracetamol containing drugs. Further refinements of the system significantly reduced therapeutic excesses of paracetamol based on weight, which had been identified as an issue when investigating Mrs Hughes’ death. However, it is my understanding that consideration is being given to changing the electronic record and prescribing system. My concern is that during any move to a new system, the safety nets introduced by the Trust will be diluted or lost.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of robust mechanisms to mitigate confirmation bias and encourage professional curiosity
Wider context from the report “5. Trust approach to mitigating against confirmation bias and encouraging professional curiosity (LGT)
Confirmation bias and a lack of professional curiosity were significant features in Mrs Hughes’ being administered two paracetamol containing drugs at the same time and in not investigating whether she had received a therapeutic excess and suffered consequential harm. I have found that the Trust does not have robust mechanism for mitigating against confirmation bias and encouraging professional curiosity.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of a mechanism for consistently recording pre-admission over-the-counter medications
Wider context from the report “4. Mechanism for recording over the counter medications taken prior to attendance at the Emergency Department (LGT)
This concern has arisen out of my finding that Mrs Hughes had taken an over the counter (OTC) drug containing paracetamol before her admission to hospital but that this had not been recorded as part of her medication history. The Trust’s Medicines Reconciliation Policy requires that patients should be asked about OTCs. The Trust relies on individual clinical practice. There is no mechanism to ensure that pre-admission OTCs are consistently recorded such that the risk of therapeutic excess of paracetamol (or other drugs available OTC) in those circumstances continues to exist.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Insufficient guidance for accurate and consistent assessment of the ACVPU confusion element
Wider context from the report “3. The assessment of the ACVPU score (LGT, RCP, NHSE)
This concern has arisen out of the fact that Mrs Hughes was scored as alert when she was confused. Confusion would have added a score of 3 to her NEWS2 score and would have resulted in an earlier escalation of her condition. I heard that confusion is not always easy to identify and that the signs can be subtle.
(1) LGT
The Trust provided training materials relating to detection and management of deteriorating patients. There was minimal guidance on how to accurately assess the ACVPU score and the confusion element in particular. There remains a tangible risk that the ACVPU score will continue to be assessed inconsistently, with new episodes of confusion continuing to be missed.
(2) NHSE, RCP
I consider that consistent and accurate assessment of the ACVPU element of the NEWS2 score is likely to a matter of wider concern. This concern is being brought to the attention of NHSE and the RCP as I consider that they have the power to support healthcare professionals to ensure consistent and accurate scoring of confusion.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of guidance or policy for deciding when virtual reviews can replace face-to-face reviews
Wider context from the report “6. Trust policy on managing virtual patient reviews (LGT)
This concern has arisen out of the fact that Mrs Hughes had been reviewed virtually rather than face to face a resident doctor on the morning before she became unwell. The Trust has no guidance or policy on virtual reviews. I was told that this is a matter of clinical judgment. The absence of any guidance to help a still relatively inexperienced resident doctor decide when they can dispense with a face-to-face review is a circumstance that creates a risk that future deaths may occur.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of a robust process for managing therapeutic excess and potential toxicity
Wider context from the report “2. Management of therapeutic excess if it has not been prevented (LGT)
This issue has arisen from the finding that once the concurrent prescription had been identified, there had no attempt to consider whether there had been a therapeutic excess and whether Mrs Hughes had suffered harm. The Trust’s response to the incident focused on prevention. It did not consider the adequacy of the clinical response once the overdose had been identified. The Trust relies on information sharing of learning from incidents and thereafter places reliance on individual clinical practice. I received no evidence of a robust process for ensuring a consistent clinical response to the management of therapeutic excess and the potential for toxicity.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Risk of loss or dilution of prescribing safety nets during electronic system changes
Wider context from the report “1. In respect of preventing concurrent prescriptions of paracetamol containing drugs and otherwise preventing prescribing errors resulting in therapeutic excess of paracetamol (NHSE, RPS, Cerner, MHRA, LGT)
(1) NHSE, RPS, Cerner, MHRA
I consider that the risk of concurrent prescriptions of paracetamol containing drugs is of wider national concern.
The Cerner prescribing system offers a duplicate checking functionality that is not a standard feature. It is hard stop and can be overridden and was not adopted by the LGT when the system was introduced. All the healthcare professionals were aware that co-codamol contained paracetamol and should not be prescribed with paracetamol. However, the 2 prescribing doctors failed to recognise that Mrs Hughes was already prescribed a paracetamol containing drug. 2 nurses failed to recognise they were administering 2 paracetamol containing drugs. A pharmacist failed to identify the concurrent prescriptions during reconciliation.
(2) LGT
LGT’s response to the incident was swift and commendable. A hard stop was introduced to the electronic prescribing system which eliminated concurrent prescriptions of paracetamol containing drugs. Further refinements of the system significantly reduced therapeutic excesses of paracetamol based on weight, which had been identified as an issue when investigating Mrs Hughes’ death. However, it is my understanding that consideration is being given to changing the electronic record and prescribing system. My concern is that during any move to a new system, the safety nets introduced by the Trust will be diluted or lost.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Liaise with NHS England about preventing prescribing systems from dispensing two concurrent medicines containing paracetamol.
Verbatim wording from the response “We have liaised with NHSE with regard to the ability of the prescribing system to dispense two concurrent medicines containing paracetamol and we understand they will incorporate learning from this incident into the commissioning of the ePRaSE tool.” Source location Response from Medicines & Healthcare Products Regulatory Agency
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation NHSE is responsible for incorporating incident learning into commissioning the ePRaSE prescribing system.
Verbatim wording from the response “We have liaised with NHSE with regard to the ability of the prescribing system to dispense two concurrent medicines containing paracetamol and we understand they will incorporate learning from this incident into the commissioning of the ePRaSE tool.” Source location Response from Medicines & Healthcare Products Regulatory Agency
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Statutory labelling, prescribing information and ongoing safety monitoring address risks associated with paracetamol overdose.
Verbatim wording from the response “In response to your concern, 1(1), the use of paracetamol and accidental overdose is a safety concern, especially in relation to the many trade names of non-prescription and prescription medicines containing paracetamol. Therefore the Human Medicines Regulations 2012, contain a number of conditions for the presentation of these medicines to highlight the presence of paracetamol in a medicine.” Source location Response from Medicines & Healthcare Products Regulatory Agency
Open published response
19 Sep 2025 Mr Luke John Chatterton · Prevention of Future Deaths report South London
View report summary
Concerns raised 4 Lack of a national formal guideline for management of bowel obstruction View source Delays in accessing advanced life support resuscitation for detained patients View source Failure of mental health hospitals to provide advanced life support resuscitation without acute hospital co-location View source Failure to identify the risks of deterioration and death from suspected acute obstruction in patients chronically on Clozapine View source See 1 more concern
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Mr Luke John Chatterton · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Mr Luke John Chatterton had a history of Clozapine-related constipation and developed vomiting, severe pain and suspected intestinal obstruction. He was discharged from the emergency department after an X-ray, later deteriorated and suffered a cardiac arrest, with delays in advanced life support before he died. The principal concerns were the safety and timeliness of resuscitation for detained mental health patients and the identification and escalation of risks associated with suspected obstruction in patients taking Clozapine.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of a national formal guideline for management of bowel obstruction
Wider context from the report “2. The acute Trust has taken a number of steps to facilitate identifying the risks of a patient who is referred with suspected obstruction. Outstanding is the development with the mental health Trust of an educational package and guidelines for managing suspected acute obstruction, including pseudo-obstruction (a complication of Clozapine) and recognizing the rare but potentially fatal risks of anti-psychotics. There is currently no national formal guideline on management of bowel obstruction. Given the rarity of antipsychotic induced acute obstruction, there seems to be merit in alerting national professional bodies to enable consideration to be given to the development of a guideline, which might identify the use of red flags to escalate and investigate those at most risk.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Delays in accessing advanced life support resuscitation for detained patients
Wider context from the report “1. The delays in accessing advanced life support (ALS) resuscitation in the MH hospital were worse than expected in the community. London Ambulance Service target for Category 1 calls is 7 minutes and yet it took 37 minutes before the paramedics arrived. Despite concerns that resuscitation skills were better to maintain in a MH Trust, Adrenaline and IV lines were part of the system at the time. Initially no IV line could be found, then none could be inserted. 25 minutes of asystole elapsed before Adrenaline was administered. Evidence was heard that MH Trusts cannot safely provide advanced life support resuscitation unless they are co-located with an acute hospital site. The National Quality Standards in mental health in patient care requires calling 999 immediately and strongly recommends provision of IV-line insertion and drug administration and a team leader with ALS skills, but the Resuscitation Council has apparently approved the Trust policy. Thus, the safety of a patient detained by the State, who has a cardio-respiratory arrest, would seem to vary according to post code, some not being close to acute hospital standards, and might even be worse than in the community. Given that those who suffer psychosis have increased risks of premature death, including suicide and cardiovascular deaths, in part related to treatment, the State would seem to have a responsibility to mitigate these risks, when compulsorily detaining them. It raises the question as to whether patients with high risk should have the right to choose a site where there is co-location of acute services and whether units with high concentration of detained psychotics should and can be safely equipped to provide Advanced Life Support.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of mental health hospitals to provide advanced life support resuscitation without acute hospital co-location
Wider context from the report “1. The delays in accessing advanced life support (ALS) resuscitation in the MH hospital were worse than expected in the community. London Ambulance Service target for Category 1 calls is 7 minutes and yet it took 37 minutes before the paramedics arrived. Despite concerns that resuscitation skills were better to maintain in a MH Trust, Adrenaline and IV lines were part of the system at the time. Initially no IV line could be found, then none could be inserted. 25 minutes of asystole elapsed before Adrenaline was administered. Evidence was heard that MH Trusts cannot safely provide advanced life support resuscitation unless they are co-located with an acute hospital site. The National Quality Standards in mental health in patient care requires calling 999 immediately and strongly recommends provision of IV-line insertion and drug administration and a team leader with ALS skills, but the Resuscitation Council has apparently approved the Trust policy. Thus, the safety of a patient detained by the State, who has a cardio-respiratory arrest, would seem to vary according to post code, some not being close to acute hospital standards , and might even be worse than in the community. Given that those who suffer psychosis have increased risks of premature death, including suicide and cardiovascular deaths, in part related to treatment, the State would seem to have a responsibility to mitigate these risks, when compulsorily detaining them. It raises the question as to whether patients with high risk should have the right to choose a site where there is co-location of acute services and whether units with high concentration of detained psychotics should and can be safely equipped to provide Advanced Life Support.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to identify the risks of deterioration and death from suspected acute obstruction in patients chronically on Clozapine
Wider context from the report “2. The acute Trust has taken a number of steps to facilitate identifying the risks of a patient who is referred with suspected obstruction. Outstanding is the development with the mental health Trust of an educational package and guidelines for managing suspected acute obstruction , including pseudo-obstruction (a complication of Clozapine) and recognizing the rare but potentially fatal risks of anti-psychotics . There is currently no national formal guideline on management of bowel obstruction. Given the rarity of antipsychotic induced acute obstruction, there seems to be merit in alerting national professional bodies to enable consideration to be given to the development of a guideline, which might identify the use of red flags to escalate and investigate those at most risk.
” Open source report
19 Aug 2025 Venetia Clarissa Pierce · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 3 Failure of nitrofurantoin safety alert criteria to cover patients without pre-existing pulmonary disease View source Failure of the surgery EMIS system to display MHRA nitrofurantoin safety alerts View source Limited clinician awareness of nitrofurantoin pulmonary damage and respiratory failure in elderly patients View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Venetia Clarissa Pierce · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Venetia Clarissa Pierce, described as an elderly frail lady with recurrent urinary infections, was prescribed nitrofurantoin prophylactically in February 2024 and died in hospital on 30 December 2024. The inquest recorded nitrofurantoin-induced pneumonitis as the medical cause of death, with frailty contributing. Concerns included the absence of an MHRA safety alert on the surgery’s EMIS system and limited awareness among clinicians of the potential for pulmonary damage and respiratory failure from nitrofurantoin in elderly patients.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of nitrofurantoin safety alert criteria to cover patients without pre-existing pulmonary disease
Wider context from the report “a. The MHRA issued a drug safety alert regarding the risks of pulmonary and hepatic adverse drug reactions in relation to nitrofurantoin in April 2023. However, no MHRA safety alert appeared on the surgery EMIS system when the drug was prescribed to Mrs Pierce. The court heard that the safety alert only arises when patients have a pre-existing pulmonary disease which Mrs Pierce did not have .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of the surgery EMIS system to display MHRA nitrofurantoin safety alerts
Wider context from the report “a. The MHRA issued a drug safety alert regarding the risks of pulmonary and hepatic adverse drug reactions in relation to nitrofurantoin in April 2023. However, no MHRA safety alert appeared on the surgery EMIS system when the drug was prescribed to Mrs Pierce . The court heard that the safety alert only arises when patients have a pre-existing pulmonary disease which Mrs Pierce did not have.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Limited clinician awareness of nitrofurantoin pulmonary damage and respiratory failure in elderly patients
Wider context from the report “b. Although a “recognised” complication, understanding of the potential for pulmonary damage and respiratory failure from use of nitrofurantoin in the elderly may remain low . The court heard evidence from a respiratory consultant that awareness amongst GPs, hospital clinicians including urologists was limited and that even if Mrs Pierce had been referred to hospital earlier the condition might not have been diagnosed.
” Open source report
7 May 2025 Sybil Morgan-Gray · Prevention of Future Deaths report Inner North London
View report summary
Concerns raised 1 Failure of blood gas machines to clearly indicate unrecordably low blood glucose levels View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Sybil Morgan-Gray · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Sybil Morgan-Gray developed hypoglycaemia in hospital, which was not recognised for several hours and resulted in a consequential brain injury. She later died from an infection arising from earlier abdominal surgery; the principal concern was that blood gas analysers displayed unrecordably low glucose as “- - -”, which could be misinterpreted and delay clinical action.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of blood gas machines to clearly indicate unrecordably low blood glucose levels
Wider context from the report “1. A concern regarding the interpretation of blood gas machine readings. Specifically, when blood glucose levels are unrecordably low, the machines report this as ‘- - -’. This display can be misinterpreted as indicating the sample is unanalysable, rather than accurately reflecting an extremely low glucose level. This misinterpretation could lead to delayed or inappropriate clinical responses, potentially resulting in future deaths.
It was unclear why the results are not recorded as ‘Low’ or similar.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Share applicable report details with the manufacturer for review through its ongoing post-market surveillance.
Verbatim wording from the response “It is our intention to share applicable details of this report with the manufacturer so that they can review this case as part of their on-going post market surveillance activities, and to work with the trust to resolve any identified training issues that may have arisen. We will also engage with NHS England colleagues to determine if any additional similar cases have been reported to Learn from Patient Safety Events and if there are, will work with NHSE to ensure appropriate training is in place.” Source location Response from Medicines & Healthcare products Regulatory Agency
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Investigate whether interpretation of glucose and other out-of-range point-of-care analyser results presents a wider safety issue.
Verbatim wording from the response “It is therefore important that device users are familiar with any warnings or symbols displayed on the device and the recommended course of action, particularly when results fall outside of the reporting range. We have investigated whether there is a wider issue across all point of care analysers and can confirm that we have not identified any further safety signals reported through our Yellow Card scheme associated with the interpretation of glucose results, or any other point of care results, outside the reporting range.” Source location Response from Medicines & Healthcare products Regulatory Agency
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Work with the trust to resolve any identified training issues relating to interpretation of analyser results.
Verbatim wording from the response “It is our intention to share applicable details of this report with the manufacturer so that they can review this case as part of their on-going post market surveillance activities, and to work with the trust to resolve any identified training issues that may have arisen. We will also engage with NHS England colleagues to determine if any additional similar cases have been reported to Learn from Patient Safety Events and if there are, will work with NHSE to ensure appropriate training is in place.” Source location Response from Medicines & Healthcare products Regulatory Agency
Open published response
Concerns raised 3 Failure to provide purchasers with warnings about the risks of high-risk lap belts View source Unrestricted online availability of high-risk healthcare equipment to untrained purchasers View source Failure to provide guidance on professional supervision or fitting of lap belts View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Susan Marion LAKIN · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Susan Marion Lakin, a 72-year-old woman with progressive mobility and memory decline, died after sliding beneath an armchair lap belt that became caught around her neck. The report raises concerns that high-risk lap belts were available to purchase online without adequate warnings about risks such as strangulation or guidance from a healthcare professional.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to provide purchasers with warnings about the risks of high-risk lap belts
Wider context from the report “The advertisement and sales particulars for the lap belt that they purchased states “fits any armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient will... suffer any injuries, tilting or slipping”.
The advertisement and sales particulars contain no warning about the risks that are associated with the use of the lap belt , nor any suggestion that the lap belt should be used or fitted under the guidance/supervision of a therapist or medical professional.
The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation .
It is concerning that people who have no healthcare training at all can purchase high risk equipment for their loved ones online without being appraised of those risks or even being informed about the high risk nature of the equipment . Lap belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with the use of the same.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unrestricted online availability of high-risk healthcare equipment to untrained purchasers
Wider context from the report “The advertisement and sales particulars for the lap belt that they purchased states “fits any armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient will... suffer any injuries, tilting or slipping”.
The advertisement and sales particulars contain no warning about the risks that are associated with the use of the lap belt, nor any suggestion that the lap belt should be used or fitted under the guidance/supervision of a therapist or medical professional.
The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation.
It is concerning that people who have no healthcare training at all can purchase high risk equipment for their loved ones online without being appraised of those risks or even being informed about the high risk nature of the equipment. Lap belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with the use of the same.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to provide guidance on professional supervision or fitting of lap belts
Wider context from the report “The advertisement and sales particulars for the lap belt that they purchased states “fits any armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient will... suffer any injuries, tilting or slipping”.
The advertisement and sales particulars contain no warning about the risks that are associated with the use of the lap belt, nor any suggestion that the lap belt should be used or fitted under the guidance/supervision of a therapist or medical professional .
The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation.
It is concerning that people who have no healthcare training at all can purchase high risk equipment for their loved ones online without being appraised of those risks or even being informed about the high risk nature of the equipment. Lap belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with the use of the same.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Advise OPSS of concerns about support belts and highlight the missing safety information in the ORTONES belt instructions.
Verbatim wording from the response “Given this, the MHRA has advised the relevant regulator, the Office of Product Safety and Standards (OPSS), to ensure that they are aware of your concerns.” Source location Response from The Medicine and Healthcare Products and Regulatory Agency
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review the relevant safety standard and ORTONES belt instructions for warnings concerning prescription, fitting, skin injury and strangulation risks.
Verbatim wording from the response “Warnings.
We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840-15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.” Source location Response from The Medicine and Healthcare Products and Regulatory Agency
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Inform OPSS about the ongoing investigation and include it in manufacturer communications to assess proposed corrective actions.
Verbatim wording from the response “Eurobaston S.L. has committed to the re-evaluation of the ORTONES belt design, labelling and instructions for use. Eurobaston S.L. have informed us that they will be working with Comercial Nespral S.L to determine what corrective actions can be implemented for ORTONES belts that have been distributed in the UK.
The MHRA will inform OPSS of this ongoing investigation into the sale of support belts without the appropriate warnings, including the ORTONES belt. In addition, we will include OPSS in our communications with the Eurobaston S.L, to assess the appropriateness of their corrective actions.” Source location Response from The Medicine and Healthcare Products and Regulatory Agency
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Refer wheelchair belts meeting medical-device or accessory definitions but lacking MHRA registration to the compliance team.
Verbatim wording from the response “Any wheelchair belts which would fall under the definition of a medical device or accessory and are not registered with the MHRA will be referred to the MHRA’s compliance team.” Source location Response from The Medicine and Healthcare Products and Regulatory Agency
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The Office of Product Safety and Standards is the relevant regulator for concerns about unregulated supportive belts and their warnings.
Verbatim wording from the response “In addition to the concerns regarding the ORTONES belt, we have identified several other supportive belts that are sold online that do not appear to be registered with the MHRA. However, they also make general claims, similar to the ORTONES belt, and are therefore unlikely to qualify as medical devices or accessories to a medical device.” Source location Response from The Medicine and Healthcare Products and Regulatory Agency
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Support belts marketed for general accident prevention are generally unlikely to qualify as medical devices or accessories under UK regulations.
Verbatim wording from the response “The MHRA’s Borderline team have reviewed the intended use and claims of the ORTONES belt and concluded that wheelchair belts are unlikely to meet the definition of a medical device in their own right, as the intended purpose is to prevent accidents and falls, which is not considered to be a medical purpose.” Source location Response from The Medicine and Healthcare Products and Regulatory Agency
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Addressing missing warnings for belts not classified as medical devices or accessories is outside the regulator’s remit.
Verbatim wording from the response “Warnings.
We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840-15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.” Source location Response from The Medicine and Healthcare Products and Regulatory Agency
Open published response
20 Mar 2025 Lee Derek Jamie ADAMS · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 3 Rapid absorption and dose-related effects of propranolol View source High toxicity of propranolol at small doses View source Lack of a specific antidote and reliance on hospital-based supportive treatment for propranolol overdose View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Lee Derek Jamie ADAMS · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Lee Derek Jamie ADAMS was at home alone after taking an excessive number of propranolol tablets, intending to take his own life, and was pronounced dead at 03.39 on 24 July 2020. The report highlights concerns about propranolol’s toxicity at relatively small doses, the absence of a specific antidote, and the need for doctors, particularly GPs, to be aware of the consequences of excess ingestion.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Rapid absorption and dose-related effects of propranolol
Wider context from the report “(1) Propranolol is absorbed quickly (the court heard within 30-60 minutes of ingestion) and dose related.
(2) As a drug it is very effective in what it is prescribed for being used for, for example, in the community to treat hypertension, anxiety and migraines. BUT unfortunately, it is highly toxic at even small doses.
(3) There is no specific anti-dote to a propranolol overdose, the only form of treatment is supportive and therefore hospital based.
(4) Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation High toxicity of propranolol at small doses
Wider context from the report “(1) Propranolol is absorbed quickly (the court heard within 30-60 minutes of ingestion) and dose related.
(2) As a drug it is very effective in what it is prescribed for being used for, for example, in the community to treat hypertension, anxiety and migraines. BUT unfortunately, it is highly toxic at even small doses.
(3) There is no specific anti-dote to a propranolol overdose, the only form of treatment is supportive and therefore hospital based.
(4) Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of a specific antidote and reliance on hospital-based supportive treatment for propranolol overdose
Wider context from the report “(1) Propranolol is absorbed quickly (the court heard within 30-60 minutes of ingestion) and dose related.
(2) As a drug it is very effective in what it is prescribed for being used for, for example, in the community to treat hypertension, anxiety and migraines. BUT unfortunately, it is highly toxic at even small doses.
(3) There is no specific anti-dote to a propranolol overdose, the only form of treatment is supportive and therefore hospital based.
(4) Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Evaluate whether a Drug Safety Update article would increase doctors’ awareness of propranolol overdose risks.
Verbatim wording from the response “In response to your matter of concern that ‘Doctors and specifically GPs should be aware of the consequences, at relatively small doses, of excess propranolol ingestion; especially when there is no specific anti-dote and treatment is restricted to supportive measures only’ we are currently evaluating whether an article in the MHRA’s safety bulletin for healthcare professionals ‘Drug Safety Update’ would be an effective way to further increase the awareness of doctors of the risks of propranolol in overdose.” Source location Response from Medicines and Healthcare products Regulatory Agency
Open published response
14 Mar 2025 Dominic Martin PHILIP · Prevention of Future Deaths report Northamptonshire
View report summary
Concerns raised 3 Unexplained exposure to Lidocaine, including for people allergic to Lidocaine View source Lack of pre-injection identification of potential allergy to iodinated contrast agents View source Failure to maintain accountable removal and stock counts for Lidocaine View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Dominic Martin PHILIP · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Dominic Martin Philip died at Kettering General Hospital on 3 February 2023 from an anaphylactic reaction to contrast medium injected for an abdominal CT scan. Concerns included whether potential allergies to contrast medium could be identified before injection, the unexplained presence of Lidocaine in his blood despite his disclosed Lidocaine allergy, and controls over the storage and removal of Lidocaine.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unexplained exposure to Lidocaine, including for people allergic to Lidocaine
Wider context from the report “b) Mr Philip did disclose an allergy to Lidocaine. The toxicology report records that Lidocaine was detected in Mr Philip’s blood post-mortem. Despite the hospital conducting a comprehensive review of the care provided, it has not been possible to ascertain why Lidocaine was present in Mr Philip’s system . Aside from the contrast medium, the only medication that Mr Philip received at hospital was IV Tazocin, IV paracetamol, Oramorph and IV saline. The toxicologist has also ruled out any possibility of contamination of the blood sample during testing. The toxicologist adds “I note that Mr Philip described as healthy so I would not expect its use outside a hospital setting”. There was no other source identified at inquest . I am therefore concerned that Mr Philip has come into contact with Lidocaine without any explanation – could there be a contaminated supply of medication? Have there been any similar unexplained occurrences anywhere else in the country? This is of course of particular concern to those who, like Mr Philip, are allergic to Lidocaine .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of pre-injection identification of potential allergy to iodinated contrast agents
Wider context from the report “a) It was stated in evidence that - an X-Ray is no longer preferred as it is not sensitive enough and a smaller obstruction might be missed; anaphylactic type reactions to iodinated contrast agents are rare accounting for 0.6% of cases with only 0.04% considered aggressive; and almost all contrast reactions that are life threatening occur within 20 minutes of intravenous injection. The current policy appears to be that a patient referred for a CT scan by the Emergency Department is to be accompanied by a doctor trained in advanced life support (ALS). In Mr Philip’s case, he was accompanied by a Core Trainee Year 2 who had ALS training. The policy for planned/outpatient interventions was not fully explored at inquest, but there was a suggestion that there might be some possibility testing for an allergic reaction to the contrast medium in advance of such an appointment? My concern is that if a patient has never before had contrast medium (as was the case with Mr Philip) they cannot possibly know if they have an allergy to it . Making arrangements for ALS after the event seems reactionary and I wondered if any other options might be available which would flag a potential allergy before the contrast is injected .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to maintain accountable removal and stock counts for Lidocaine
Wider context from the report “c) It has also been brought to my attention in a different case currently under investigation within my jurisdiction that as Lidocaine is a prescription only medication, it needs to be stored in a locked cupboard. However, Lidocaine is not a Controlled Drug which means that clinicians do not need a double signature to remove the medication from the stock and it is not subject to a count of the stock each time an ampoule is used . The Hospital has stated that “The use of Lidocaine will vary within each area dependant on the patients being seen within each department and treatments given. Stock levels are reviewed by pharmacy to ascertain stock required. Unless a large amount of stock was removed from a single clinical area there would be no alert to indicate that Lidocaine was being removed for reasons other than patient treatment ”.
” Open source report
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation No product contamination issues involving lidocaine or similar unexplained occurrences have been identified through surveillance.
Verbatim wording from the response “Based on the MHRA’s pharmacovigilance and post-marketing surveillance activities, we are also not aware of any product contamination issues with prescription only medicines or medical devices in relation to contamination with lidocaine, nor any similar unexplained occurrences elsewhere in the country.” Source location Response from Medicines & Healthcare Products Regulatory Agency
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Decisions about additional lidocaine governance processes belong to the relevant medicines management committee at the local NHS Trust.
Verbatim wording from the response “It should be noted that lidocaine is contained in multiple drug formulations which can be administered by different routes, including during medical procedures in the emergency department. Therefore, the consideration of additional governance processes for the management of lidocaine (such as double signatures) should be carefully considered to avoid undue delay to patient access and minimise additional burden on healthcare professionals. As this is not a decision for the MHRA we would advise that additional guidance is sought from the relevant medicines management committee at the local NHS Trust.” Source location Response from Medicines & Healthcare Products Regulatory Agency
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Additional handling procedures for non-controlled lidocaine are outside the remit unless a specific safety concern exists.
Verbatim wording from the response “For medicines that are not Controlled Drugs, the requirement for double signatures for stock count and supply processes is generally determined by medicine management procedures within individual hospitals and healthcare providers, who may sometimes consider more stringent controls are warranted due to a medicine’s potential for misuse, cost or other supply-related considerations. Unless there is a safety concern, any additional procedures for the handling of medicines would be outside the remit of the MHRA.” Source location Response from Medicines & Healthcare Products Regulatory Agency
Open published response
21 Feb 2025 Mr Luke Alexander Worrell · Prevention of Future Deaths report London South
View report summary
Concerns raised 2 Lack of clinical staff awareness of Clozapine's potential fatal side effects View source Inappropriate use of community treatment orders where sufficient evidence supports retention on a Mental Health Act section View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Mr Luke Alexander Worrell · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Mr Luke Alexander Worrell, who had treatment-resistant schizophrenia and was taking Clozapine, developed persistent vomiting, dehydration and an ileus before suffering a ruptured oesophagus and dying in hospital on 2 January 2021. The report identified concerns about clinical staff failing to recognise the potentially fatal gastrointestinal side effects of Clozapine and about the inappropriate use of a community treatment order instead of continued detention under a mental health section. The inquest narrative also described failures to recognise the need for face-to-face psychiatric assessment after his deterioration following discharge.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of clinical staff awareness of Clozapine's potential fatal side effects
Wider context from the report “1. The lack of awareness by a series of clinical staff of the potential fatal side effects of Clozapine
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inappropriate use of community treatment orders where sufficient evidence supports retention on a Mental Health Act section
Wider context from the report “2. Inappropriate use of community treatment order , when there was sufficient evidence to keep on a MHA section .
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Engage relevant stakeholders during the clozapine product-information review to ensure regulatory documents meet patients’ and prescribers’ needs.
Verbatim wording from the response “We continuously review the safety of medicines on the UK market and take appropriate regulatory action as required. Currently, we are reviewing the product information for clozapine. As part of this review, we will be giving careful consideration to the information which is provided to healthcare professionals, patients and their families and carers, and whether this can be improved to provide greater clarity. We intend to engage with relevant stakeholders during this process to ensure the regulatory documents meet the needs of patients and prescribers. It is anticipated that this review of clozapine will be completed this year, and we will inform you of the outcome.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review clozapine product information and consider whether warnings for healthcare professionals, patients and carers can be clarified.
Verbatim wording from the response “We continuously review the safety of medicines on the UK market and take appropriate regulatory action as required. Currently, we are reviewing the product information for clozapine. As part of this review, we will be giving careful consideration to the information which is provided to healthcare professionals, patients and their families and carers, and whether this can be improved to provide greater clarity. We intend to engage with relevant stakeholders during this process to ensure the regulatory documents meet the needs of patients and prescribers. It is anticipated that this review of clozapine will be completed this year, and we will inform you of the outcome.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Commenting on clinical decisions in specific cases, including those concerning clozapine, is outside the respondent’s remit.
Verbatim wording from the response “We have considered the evidence provided and the circumstances leading to Mr Worrell’s death and acknowledge that your concerns relate to lack of awareness of clinical staff of the potentially fatal side effects of clozapine, and clinical decisions. Unfortunately, we cannot directly address these points, as it is not within our remit to comment on the clinical decisions in specific cases.” Source location Response from MHRA
Open published response
Concerns raised 4 Failure to achieve clear communication of key information within community mental health teams View source Failure to routinely detect Clozapine-associated cardiomyopathies View source Limited provision of Clozapine side-effect and red-flag information to patients attending GP practices View source Failure to achieve clear communication of key information with other agencies involved in patient care View source See 1 more concern
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
William Antony Northcott · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
William Antony Northcott, who had treatment-resistant schizophrenia, was found deceased on 13 July 2021 after suffering a sudden fatal cardiac arrhythmia. The report raised concerns about the adequacy and consistency of information on clozapine side effects and cardiac warning signs, the detection of cardiomyopathies in patients taking clozapine, and communication between agencies and care teams.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to achieve clear communication of key information within community mental health teams
Wider context from the report “It is clear that patients suffering with treatment resistant schizophrenia are complex, and as such there are often a number of different agencies involved in an individual's care. In addition, there are often multiple members of the same team involved in an individual's care. During the inquest it became clear that, at times, communication of important issues was not as clear as it should have been . I note that Devon Partnership NHS Trust has significant training available for its staff and other agencies it engages with in relation to patients who are prescribed Clozapine. However, it would be of great assistance to understand what Devon Partnership NHS Trust is doing to ensure that optimum communication of key information is achieved within the community mental health team , and when dealing with its other agencies involved in a patient's care.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to routinely detect Clozapine-associated cardiomyopathies
Wider context from the report “The risk of myocarditis is reasonably well explained in Devon Partnership NHS Trust's policy documentation, but there is less of a focus on cardiomyopathies which would include left ventricular hypertrophy . I understand that the Trust's guidance is based on national guidance. Annual ECGs are required for patients prescribed Clozapine and questions about cardiac function will now be asked at monthly Clozapine clinics. However, I understand that ECGs are not a diagnostic tool used to assist in the diagnosis of cardiomyopathies such as left ventricular hypertrophy and that left ventricular hypertrophy can be asymptomatic. I also understand that an echocardiogram may be able to identify such cardiomyopathies, but that this is not currently required on initiation of Clozapine or routinely at any other time whilst a patient is taking Clozapine .
I am concerned that these cardiomyopathies could therefore go undetected in patients prescribed Clozapine and leave them at unknown increased risk of fatal cardiac arrhythmias, as occurred in William's case. Given that the Trust's guidance is based on national guidance I am concerned this may be a national issue.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Limited provision of Clozapine side-effect and red-flag information to patients attending GP practices
Wider context from the report “Currently around 60% of the cohort of patients prescribed Clozapine who are under the care of Devon Partnership Trust have access to these clinics. The other 40% will attend their GP surgery for their monthly Clozapine phlebotomy service. The phlebotomy service provided at a GP practice is usually an appointment with a non-qualified member of staff, who will not have been specifically trained in the side effects of Clozapine. I am therefore concerned that the level of care provided to patients attending Clozapine clinics on a monthly basis, is likely to be superior to the care provided to those patients who attend their GP practice. In particular, I am concerned that any discussion and repetition of information surrounding red flags and side effects associated with Clozapine, and advice about when to seek medical attention, will be significantly more limited for those patients attending their GP practice than for those attending the monthly Clozapine clinics. I am also concerned that this limitation is likely to extend further than the 40% of patients in receipt of Clozapine under the care of Devon Partnership NHS Trust and that this may be a national issue.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to achieve clear communication of key information with other agencies involved in patient care
Wider context from the report “It is clear that patients suffering with treatment resistant schizophrenia are complex, and as such there are often a number of different agencies involved in an individual's care. In addition, there are often multiple members of the same team involved in an individual's care. During the inquest it became clear that, at times, communication of important issues was not as clear as it should have been . I note that Devon Partnership NHS Trust has significant training available for its staff and other agencies it engages with in relation to patients who are prescribed Clozapine. However, it would be of great assistance to understand what Devon Partnership NHS Trust is doing to ensure that optimum communication of key information is achieved within the community mental health team, and when dealing with its other agencies involved in a patient's care.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Engage relevant stakeholders during the clozapine product-information review to ensure regulatory documents meet patients’ and prescribers’ needs.
Verbatim wording from the response “The MHRA continuously reviews the safety of medicines on the UK market and take appropriate regulatory action as required. Currently, the MHRA is reviewing the product information for clozapine. As part of this review, we will be giving careful consideration to the information which is provided to healthcare professionals, patients and their families and carers, and whether this can be improved to provide greater clarity. We intend to engage with relevant stakeholders during this process to ensure the regulatory documents meet the needs of patients and prescribers. It is anticipated that this review of clozapine will be completed this year.” Source location Response from Medicines and Healthcare Projects Regulation Authority
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review clozapine product information and consider improving its clarity for healthcare professionals, patients, families and carers.
Verbatim wording from the response “The MHRA continuously reviews the safety of medicines on the UK market and take appropriate regulatory action as required. Currently, the MHRA is reviewing the product information for clozapine. As part of this review, we will be giving careful consideration to the information which is provided to healthcare professionals, patients and their families and carers, and whether this can be improved to provide greater clarity. We intend to engage with relevant stakeholders during this process to ensure the regulatory documents meet the needs of patients and prescribers. It is anticipated that this review of clozapine will be completed this year.” Source location Response from Medicines and Healthcare Projects Regulation Authority
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Clinical discussions with prescribers and care delivered by the Trust fall outside the regulator’s remit, so it cannot directly address them.
Verbatim wording from the response “We have considered the evidence provided and the circumstances leading to Mr Northcott’s death and acknowledge that most of your concerns relate to clinical discussions between a patient and their prescriber or via the clinical care delivered by the Trust. Unfortunately, the MHRA cannot directly address these points, as it is not within our remit to comment on the clinical care in specific cases.” Source location Response from Medicines and Healthcare Projects Regulation Authority
Open published response
13 Jan 2025 Angela Stacey Carney · Prevention of Future Deaths report West Yorkshire (Western)
View report summary
Concerns raised 2 Lack of an independent secondary braking mechanism in some mobility scooters View source Potential safety hazards from use of older second-hand mobility scooters View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Angela Stacey Carney · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
On 26 September 2023, Angela Stacey Carney suffered fatal injuries after her mobility scooter travelled at speed down Westcliffe Road and into the path of a pickup at a junction. The scooter was in freewheel mode, which prevented braking, and the report raised concerns about the absence of an independent fail-safe braking mechanism and the safety of older second-hand mobility scooters.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of an independent secondary braking mechanism in some mobility scooters
Wider context from the report “Although it is my understanding that more recently designed and manufactured mobility scooters are manufactured with a secondary braking system by way of a fitted hand brake mechanism, I am concerned that other manufacturers may be producing scooters without such an independent braking mechanism .
I also have a concern that there may be many other older second hand models on the second hand market that are being used, which all combined has worrying safety implications for the rider’s and members of the public.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Potential safety hazards from use of older second-hand mobility scooters
Wider context from the report “Although it is my understanding that more recently designed and manufactured mobility scooters are manufactured with a secondary braking system by way of a fitted hand brake mechanism, I am concerned that other manufacturers may be producing scooters without such an independent braking mechanism.
I also have a concern that there may be many other older second hand models on the second hand market that are being used , which all combined has worrying safety implications for the rider’s and members of the public .
” Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Continue monitoring reports and analysing emerging safety patterns concerning mobility-scooter braking mechanisms in freewheel mode.
Verbatim wording from the response “While we have received a relatively low number of reports potentially related to braking issues when in freewheel mode, we acknowledge the severity of harm that can occur if the device is not equipped with appropriate stopping mechanisms. We will therefore take the necessary steps to try and address the concerns raised. We will continue to monitor reports concerning” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Collaborate with relevant stakeholders to disseminate the updated mobility-scooter guidance and emphasize freewheel-mode safety features.
Verbatim wording from the response “4. We are aware of complexities associated with the use and purchase of mobility scooters, including the use of devices beyond their intended service life, purchase of second-hand devices from unauthorised retailers, and use of devices that are not safe. In addition to the existing guidance on the safe use of assistive technology devices¹, the MHRA is working on updating Medical devices: information for users and patients guidance to raise awareness on important considerations prior to purchasing a mobility scooter. The updated guidance will include key points for potential users to be aware of before purchasing their mobility scooter, including links to documents produced from other organisations to further strengthen the advice. The update is expected to be published by June 2025. We will inform you once the guidance is updated.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review the current BS EN 12184:2022 provisions governing braking, emergency stopping, freewheel devices, alarms and speed-related safety in mobility scooters.
Verbatim wording from the response “2. We have reviewed the current version of the standard BS EN 12184:2022 ‘Electrically powered wheelchairs, scooters and their chargers’. Requirements and test methods and the following provisions related to freewheel mode / device are included in the standard:” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Sample registered powered-mobility-scooter manufacturers to evaluate whether UK-market devices have adequate safeguards against unintended movement in freewheel mode.
Verbatim wording from the response “3. Using the data from our Registration Database, we have identified manufacturers who have registered with the MHRA as manufacturers of powered mobility scooters. We will sample a number of these manufacturers to evaluate the extent to which mobility scooters placed on the market in the UK are equipped with adequate safety features to mitigate the risk of unintended and uncontrolled movement while in freewheel mode. Following this initial review and based on its findings, we will undertake appropriate regulatory actions.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Update Medical devices: information for users and patients guidance with safety considerations for purchasing mobility scooters, including relevant external resources.
Verbatim wording from the response “4. We are aware of complexities associated with the use and purchase of mobility scooters, including the use of devices beyond their intended service life, purchase of second-hand devices from unauthorised retailers, and use of devices that are not safe. In addition to the existing guidance on the safe use of assistive technology devices¹, the MHRA is working on updating Medical devices: information for users and patients guidance to raise awareness on important considerations prior to purchasing a mobility scooter. The updated guidance will include key points for potential users to be aware of before purchasing their mobility scooter, including links to documents produced from other organisations to further strengthen the advice. The update is expected to be published by June 2025. We will inform you once the guidance is updated.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing standards comprehensively specify braking and freewheel safety requirements without requiring a particular independent hand-brake mechanism.
Verbatim wording from the response “2. We have reviewed the current version of the standard BS EN 12184:2022 ‘Electrically powered wheelchairs, scooters and their chargers’. Requirements and test methods and the following provisions related to freewheel mode / device are included in the standard:” Source location Response from MHRA
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Regulating the sale of second-hand medical devices is outside the respondent’s remit.
Verbatim wording from the response “While the MHRA does not regulate the sale of second-hand medical devices, where possible, we work with a range of stakeholders including patients and the public to work towards the promotion of safer medical devices and their safe use.” Source location Response from MHRA
Open published response
7 Jan 2025 Thomas Henry Robin Kingston · Prevention of Future Deaths report Gloucestershire
View report summary
Concerns raised 2 Inadequate guidance on persisting with or switching SSRI medication when there is no benefit or adverse side effects View source Inadequate communication of suicide risks associated with SSRI medications View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Thomas Henry Robin Kingston · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Thomas Henry Robin Kingston, a 45-year-old man, died after sustaining a self-inflicted shotgun wound to the head at his parents’ property on 25 February 2024. The report raises concerns about communication of suicide risks associated with SSRI medication and whether guidance to continue or switch SSRI medication is appropriate when there is no benefit or adverse side effects are experienced.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate guidance on persisting with or switching SSRI medication when there is no benefit or adverse side effects
Wider context from the report “2. Whether the current guidance to persist with SSRI medication or switch to an alternative SSRI medication is appropriate when no benefit has been achieved and/ or especially when any adverse side effects are being experienced .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Inadequate communication of suicide risks associated with SSRI medications
Wider context from the report “1. Whether there is adequate communication of the risks of suicide associated with the selective serotonin reuptake inhibitor (SSRI) medications ,
” Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Communicate updates on the presentation of suicidal-behaviour risks in antidepressant leaflets to healthcare professionals, patient groups and relevant voluntary organisations after the review and subsequent advice.
Verbatim wording from the response “The considerations of the EWG are anticipated to complete in 2025. We will communicate to healthcare professionals, patient groups and relevant voluntary organisations any updates on how the risk of suicidal behaviours associated with antidepressants is presented in the antidepressant PILs following the conclusions of the EWG and subsequent CHM advice.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Conduct an Expert Working Group review of how suicidal-behaviour risks are communicated in antidepressant leaflets, including engagement with patient charities and bereaved families.
Verbatim wording from the response “In 2022, the MHRA sought the advice of the Commission on Human Medicines (CHM) on the need to convene an Expert Working Group (EWG) to review how the risk of suicidal behaviours is communicated in the patient leaflets to establish if this can be improved or if it would be more helpful for patients to receive this information in different formats within the regulatory framework. The first meeting of the EWG was held on 4 July 2024. Round table meetings involving patient charities and families of those bereaved by suicide will be held in March 2025. The membership and remit of the EWG can be found here Commission on Human Medicines - GOV.UK.” Source location Response from MHRA
Open published response
17 Dec 2024 Susan Marie Karakoc · Prevention of Future Deaths report Nottinghamshire
View report summary
Concerns raised 3 Search engines readily returning websites selling potentially fatal prescription medications View source Failure of prescription medication supply-chain legitimacy monitoring to prevent ready online supply View source Failure of systems to detect criminal medication supply enterprises and alert relevant authorities View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Susan Marie Karakoc · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Susan Marie Karakoc collapsed at home on 1 December 2023 and died in hospital the following day after suffering a hypoxic brain injury. The report states that she obtained prescription medications from online sources selling medicines off-label, and that toxicological examination identified toxicity associated with the chain of events leading to her death. Concerns included the ready availability of such websites through search engines, inadequate monitoring of online medication supply chains, and ineffective detection of financial services supporting criminal enterprises.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Search engines readily returning websites selling potentially fatal prescription medications
Wider context from the report “1. There is evidence of search engines readily returning websites which sell prescription medications , including those that sell highly addictive sleeping tablets and painkillers which can and do cause fatalities . I am concerned how readily search engines return websites such as these ;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of prescription medication supply-chain legitimacy monitoring to prevent ready online supply
Wider context from the report “2. I am concerned that the current system for monitoring the legitimacy of supply chains for medications available in England and Wales via prescription is not preventing the ready supply of such medications online ;
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of systems to detect criminal medication supply enterprises and alert relevant authorities
Wider context from the report “3. There is evidence that banks form a legitimate part of the supply chain, and that this is crucial to the functioning of these criminal enterprises. I am concerned that the current system for detecting such criminal enterprises and alerting the relevant authorities is not effective .
” Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Investigate the accessed website and issue a domain-suspension request that resulted in its takedown.
Verbatim wording from the response “We can confirm that the website accessed by the deceased was subject to an MHRA investigation prior to the issuing of the Regulation 28 Report and a domain suspension request was issued in March 2024 resulting in the website being taken down.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Use advanced technology to identify, track and seize proceeds of medicine-related crime, including cryptocurrency.
Verbatim wording from the response “• The use of cutting-edge technology to identify, track and seize the proceeds of crime, including cryptocurrency.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Use technology with an online marketplace to identify and block unregulated medicines and medical devices before public advertising.
Verbatim wording from the response “We work closely with web-based sales platforms and the internet industry to identify and remove non-compliant medicines and medical devices where possible. Collaboration with one well-known online marketplace allowed the use of technology to identify and block more than a million unregulated medicines and medical devices before they could be advertised to the public.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Collaborate with UK banking and payment providers to disrupt payment mechanisms used by illegal prescription-medicine suppliers.
Verbatim wording from the response “• Collaboration with UK banking and payment providers to disrupt the payment mechanisms used by websites illegally supplying prescription only medicines.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Collaborate with the Office of Communications to explore preventive opportunities under the Online Safety Act.
Verbatim wording from the response “• Collaboration with the Office of Communications to explore fresh preventative opportunities presented by the Online Safety Act, which will create new rules for social media companies and search engine providers.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Enhance collaboration with search engines and UK internet service providers to block harmful content through targeted ISP filtering.
Verbatim wording from the response “• Enhanced collaboration with search engine and UK internet service providers aimed at blocking harmful content through targeted ISP-filtering.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Strengthen collaboration with UK Border Force to expand border operations and increase seizures of illegally trafficked medicines.
Verbatim wording from the response “• Boosted collaboration with UK Border Force, allowing the MHRA to grow its operational footprint at the border and increase the seizure rates of illegally trafficked medicines.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation UK authorities cannot seize illicit domains or compel registrars to suspend them, particularly where domains are beyond UK jurisdiction.
Verbatim wording from the response “The sale and supply of unregulated medical products is a global problem. Online portals play a significant role in transnational medicines crime and many websites proliferate across the internet. Currently, there is no legal mechanism for UK law enforcement to seize control of illicit domains or compel registrars to suspend them. Gaining regulatory compliance can be a difficult and sometimes impossible process, especially when domains are registered beyond the reach of UK jurisdiction.” Source location Response from MHRA
Open published response
15 Nov 2024 Yousef Al-Kharboush and 2 others · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 2 Lack of requirements for section 10 exempt entities to report adverse-event findings to the MHRA and other relevant organisations View source Unclear thresholds for section 10 entity reporting to NHSE and the CQC View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Yousef Al-Kharboush and 2 others · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Aviva Otte died in January 2014 after receiving TPN provided and compounded by an NHS establishment; the TPN was, on balance, contaminated with Bacillus cereus. Oscar Barker and Yousef Al-Kharboush died in June 2014 after receiving TPN compounded by a commercial provider that was also contaminated with Bacillus cereus. The principal concerns were unclear or absent requirements for section 10 exempt entities to report adverse-event findings and uncertainty about reporting thresholds and wider dissemination of information that could help other providers assess risks.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of requirements for section 10 exempt entities to report adverse-event findings to the MHRA and other relevant organisations
Wider context from the report “(1) There is no requirement for a section 10 exempt entity to report any of its findings to the MHRA or indeed to other Trusts or the industry in general if an adverse event occurs.
(2) The current reporting structures (for a section 10 entity) involve reporting to NHSE and the CQC but the threshold of necessity for such reporting appears unclear and, in essence, up to the Trust.
(3) There may be times when section 10 entities reach conclusions which would assist the wider industry and help to assist both other Trusts and commercial organisations in assessing their own risks and improving the provision of highly specific medication to a group of vulnerable patients.
(4) the same may also be true of commercial organisations but they have the power of the MHRA controlling and effecting recalls and actions and the wider dissemination of information.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unclear thresholds for section 10 entity reporting to NHSE and the CQC
Wider context from the report “(1) There is no requirement for a section 10 exempt entity to report any of its findings to the MHRA or indeed to other Trusts or the industry in general if an adverse event occurs.
(2) The current reporting structures (for a section 10 entity) involve reporting to NHSE and the CQC but the threshold of necessity for such reporting appears unclear and, in essence, up to the Trust.
(3) There may be times when section 10 entities reach conclusions which would assist the wider industry and help to assist both other Trusts and commercial organisations in assessing their own risks and improving the provision of highly specific medication to a group of vulnerable patients.
(4) the same may also be true of commercial organisations but they have the power of the MHRA controlling and effecting recalls and actions and the wider dissemination of information.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Maintain established DMRC communication channels for sharing defective-medicine information with the NHS compounding community.
Verbatim wording from the response “Communicating information on adverse events to other Trusts, wider industry and commercial organisations
The MHRA agrees there are potential scenarios where it could be important to promptly share information about a defective medicine prepared under a Section 10 exemption, and how the risk should be minimised, with licensed manufacturers. This will be done by the MHRA using existing and established mechanisms for communicating to licence holders. In regard to the sharing of information from the licensed manufacturing sector, the MHRA has established via the DMRC lines of communication to share information regarding defective medicines with the NHS compounding community (which includes Section 10 NHS hospital pharmacies) which are in addition to the reporting of defective medicines detailed above.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Agree and implement an MoU with NHSE for routine updates and dissemination of actionable incident learning.
Verbatim wording from the response “Accordingly, the MHRA will work with NHSE with a view to implementing a memorandum of understanding to enable appropriate categorisation and mutual dissemination of actionable safety information and learning from incidents at both an executive and operational level. The MHRA is also exploring with NHSE enabling better sharing of information with Trusts whose Section 10 NHS hospital pharmacy is under compliance monitoring by the NHS Specialist Pharmacy Services (SPS) and under the oversight of the MHRA’s IAG which, as noted above, is MHRA’s escalation route where critical failings in GMP are identified and the need for regulatory action against a licence may be required.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Explore with NHSE improved information sharing with Trusts subject to SPS compliance monitoring or MHRA escalation oversight.
Verbatim wording from the response “Accordingly, the MHRA will work with NHSE with a view to implementing a memorandum of understanding to enable appropriate categorisation and mutual dissemination of actionable safety information and learning from incidents at both an executive and operational level. The MHRA is also exploring with NHSE enabling better sharing of information with Trusts whose Section 10 NHS hospital pharmacy is under compliance monitoring by the NHS Specialist Pharmacy Services (SPS) and under the oversight of the MHRA’s IAG which, as noted above, is MHRA’s escalation route where critical failings in GMP are identified and the need for regulatory action against a licence may be required.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Remind GPhC, PSNI and CQC of responsibilities concerning Section 10 medicines and information exchange.
Verbatim wording from the response “The MHRA already has Memoranda of Understanding with the GPhC and PSNI and will use these (including updating, as necessary) to highlight the need to ensure formal exchange of information related to the preparation of Section 10 medicines. Similarly, the MHRA will enter into dialogue with the CQC which regulates other healthcare settings in England e.g. independent hospitals and their equivalents, as these may also prepare medicines under the Section 10 exemption and should also be included in the planned programme of increased clarification of roles and responsibilities, information exchange and learnings.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Use or update existing MoUs with GPhC and PSNI to support formal information exchange about Section 10 medicines.
Verbatim wording from the response “The MHRA already has Memoranda of Understanding with the GPhC and PSNI and will use these (including updating, as necessary) to highlight the need to ensure formal exchange of information related to the preparation of Section 10 medicines. Similarly, the MHRA will enter into dialogue with the CQC which regulates other healthcare settings in England e.g. independent hospitals and their equivalents, as these may also prepare medicines under the Section 10 exemption and should also be included in the planned programme of increased clarification of roles and responsibilities, information exchange and learnings.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Other Section 10 providers fall under the relevant pharmacy or healthcare regulators, rather than the MHRA.
Verbatim wording from the response “As detailed above there is a legal requirement for the holder of any manufacturer’s licence, be they commercial organisations or NHS Trusts, to notify MHRA and work with us to instigate an appropriate recall. While the matter in question relates to NHS pharmacy units, the MHRA notes that the Section 10 exemption is not limited to NHS sites. Registered pharmacies (i.e. retail/commercial pharmacies) are under the jurisdiction of the General Pharmaceutical Council (GPhC) in Wales Scotland and England and the Pharmaceutical Society of Northern Ireland (PSNI) for Northern Ireland.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Facilities preparing or assembling medicines under the Section 10 exemption fall outside the regulator’s responsibility.
Verbatim wording from the response “The Section 10 exemption
Section 10 of the Medicines Act 1968, as amended, provides scope for exemptions from the requirement to hold a manufacturer’s licence or marketing authorisation in defined circumstances. A pharmacist (or any person working under their supervision in a registered pharmacy), hospital pharmacy, or a pharmacy in a care home service or health centre to whom the Section applies may: prepare, assemble or dispense a medicinal product in accordance with a prescription given by a practitioner. Facilities that are preparing or assembling medicinal products under a Section 10 exemption fall outside the responsibility of MHRA.” Source location Response from MHRA
Open published response
13 Sep 2024 Paul Rodney Batchelor · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 5 Lack of safety information for users of nursing care beds with extensions View source Failure to formalise resident room checks in care home policy and procedures View source Failure to check residents who may be in distress View source Failure to ensure adequate support and retention of mattress extensions or bolsters on nursing care beds View source Lack of procedures for staff frightened or concerned about entering a resident’s room alone View source See 2 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Paul Rodney Batchelor · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Paul Rodney Batchelor, a frail elderly man in a care home for respite care, became wedged after a mattress extension fell through the frame of his extended nursing bed and died of positional asphyxia and bronchopneumonia. His cries for help went unattended for over an hour. The concerns were inadequate support for mattress extensions on extended beds and the lack of formalised procedures for staff responding to distressed residents at night, including when staff are frightened or concerned about entering a room alone.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of safety information for users of nursing care beds with extensions
Wider context from the report “First Concern: There may be a lack of awareness of the need to ensure adequate support for the mattress extension or bolster when using nursing care beds with an extension frame fitted.
And that without adequate support there is a risk of death in that the mattress extension can fall through the bed frame creating a sufficient gap for a person to become wedged or stuck.
The lack of awareness of the risk may be compounded because when the mattress extension is fitted into the gap between the standard mattress and the footboard it may appear as though the bolster is adequately supported. Further that over time and use mattress deck extensions or other supporting framework can become detached or lost from the bed
Since this incident the court heard evidence that the care home and its sister care home have checked all existing extended profile beds and taken steps to ensure that they are fitted with the correct support.
However, the coroner is concerned that users of nursing care beds with extensions may need to be made aware of the circumstances of this death to prevent other deaths in similar circumstances .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to formalise resident room checks in care home policy and procedures
Wider context from the report “Second Concern: The coroner notes that the care home has taken steps to ensure that any resident in distress and calling for help at night is heard. However, though the coroner has been shown minutes of briefings to care home staff conducted after Mr Batchelor’s death emphasising the need to conduct checks of residents by going into a resident’s room, she remains concerned that such briefings have not been formalised into care home policy and procedures . Nor do the minutes of those briefings explain what staff should do if they are frightened or concerned about entering a room on their own. There is the risk that rather than disturb a resident care home staff through, for example, fear or lack of time do not check a resident who may be in distress.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to check residents who may be in distress
Wider context from the report “Second Concern: The coroner notes that the care home has taken steps to ensure that any resident in distress and calling for help at night is heard. However, though the coroner has been shown minutes of briefings to care home staff conducted after Mr Batchelor’s death emphasising the need to conduct checks of residents by going into a resident’s room, she remains concerned that such briefings have not been formalised into care home policy and procedures. Nor do the minutes of those briefings explain what staff should do if they are frightened or concerned about entering a room on their own. There is the risk that rather than disturb a resident care home staff through, for example, fear or lack of time do not check a resident who may be in distress .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure adequate support and retention of mattress extensions or bolsters on nursing care beds
Wider context from the report “First Concern: There may be a lack of awareness of the need to ensure adequate support for the mattress extension or bolster when using nursing care beds with an extension frame fitted .
And that without adequate support there is a risk of death in that the mattress extension can fall through the bed frame creating a sufficient gap for a person to become wedged or stuck .
The lack of awareness of the risk may be compounded because when the mattress extension is fitted into the gap between the standard mattress and the footboard it may appear as though the bolster is adequately supported. Further that over time and use mattress deck extensions or other supporting framework can become detached or lost from the bed
Since this incident the court heard evidence that the care home and its sister care home have checked all existing extended profile beds and taken steps to ensure that they are fitted with the correct support.
However, the coroner is concerned that users of nursing care beds with extensions may need to be made aware of the circumstances of this death to prevent other deaths in similar circumstances.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of procedures for staff frightened or concerned about entering a resident’s room alone
Wider context from the report “Second Concern: The coroner notes that the care home has taken steps to ensure that any resident in distress and calling for help at night is heard. However, though the coroner has been shown minutes of briefings to care home staff conducted after Mr Batchelor’s death emphasising the need to conduct checks of residents by going into a resident’s room, she remains concerned that such briefings have not been formalised into care home policy and procedures. Nor do the minutes of those briefings explain what staff should do if they are frightened or concerned about entering a room on their own . There is the risk that rather than disturb a resident care home staff through, for example, fear or lack of time do not check a resident who may be in distress.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Host a round table with stakeholders to discuss updating bed-rail safety guidance and raising awareness of entrapment and injury risks.
Verbatim wording from the response “The MHRA carried out a review of deaths and serious injuries involving beds and bed rails in October 2022. In January 2023, the MHRA hosted a round table to discuss updating the Guidance on safe use and management of bed rails and how to raise awareness of the risks of death and serious injury with beds, bed rails, and other associated devices. As a result of these discussions, a National Patient Safety Alert on the risk of death from entrapment or falls with medical beds, trolleys, bed rails, bed grab handles and lateral turning devices was published in August 2023, two months after the sad death of Mr Batchelor.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Publish a National Patient Safety Alert addressing entrapment and falls involving medical beds, bed rails and associated devices, with requirements for training, management systems, maintenance and risk assessment.
Verbatim wording from the response “The MHRA carried out a review of deaths and serious injuries involving beds and bed rails in October 2022. In January 2023, the MHRA hosted a round table to discuss updating the Guidance on safe use and management of bed rails and how to raise awareness of the risks of death and serious injury with beds, bed rails, and other associated devices. As a result of these discussions, a National Patient Safety Alert on the risk of death from entrapment or falls with medical beds, trolleys, bed rails, bed grab handles and lateral turning devices was published in August 2023, two months after the sad death of Mr Batchelor.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Continue monitoring reports of entrapment involving beds and associated devices for adverse safety signals.
Verbatim wording from the response “In general, where an adverse incident occurs the manufacturer of a medical device is responsible for carrying out any investigation required and informing MHRA of their findings. We regularly review our database of incidents to detect safety signals and consider whether additional action is required. Where necessary we will issue safety messages to health and care organisations, patients, and the public. These types of actions help to reduce the risk of similar incidents happening again.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Develop training materials with NAMDET for bed and bed-rail users on entrapment risks.
Verbatim wording from the response “The MHRA has discussed with the NAMDET the possibility of producing training materials for users of beds and bed rails, and the risks relating to entrapment, and this is currently being drafted, with a view to be available in the coming months.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Disseminate the National Patient Safety Alert through the Central Alerting System and provide implementation support, including MDSO-network input, FAQs and advice to healthcare and care organisations.
Verbatim wording from the response “This Alert was directed towards care home staff, among others, and was sent to relevant organisations via the MHRA’s Central Alerting System on 30 August 2023 and was also highlighted in the CQC’s Adult Social Care Bulletin on 28 September 2023. The MHRA attended meetings with Medical Device Safety Officer (MDSO) network on implementation of the Alert and provided input into the MDSO network’s FAQs for this Alert. The is available both on the MDSO network (restricted access) and also on the National Association of Medical Device Educators and Trainers (NAMDET) webpage (public access). The MHRA has also provided advice on the Alert wherever requested, including from various NHS organisations, local councils, care homes and manufacturers.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing national patient safety alert requirements are sufficient to prevent entrapment involving bed extensions, so no further action is intended.
Verbatim wording from the response “We suggest that the above list of actions detailed in the National Patient Safety Alert, published two months after Mr Batchelor’s death, are relevant to this case. Neither the MHRA nor the manufacturer have received any similar reports with the Medley Ergo bed, and the MHRA does not have any similar reports for other beds either, relating to the bed extension. The MHRA has published a National Patient Safety Alert with general requirements to prevent entrapment with beds and associated devices and based on the lack of similar reports to bed extensions, we believe these requirements are sufficient, and we therefore do not intend to take further action.” Source location Response from MHRA
Open published response
4 Jul 2024 David John Morris · Prevention of Future Deaths report East London
View report summary
Concerns raised 9 Poor communication in cancer diagnosis and treatment View source Failure of serious incident investigations to identify relevant reviewing clinicians View source Failure to treat and escalate suspected sepsis promptly View source Poor organisation of cancer diagnosis and treatment View source Ineffective controlled drug management systems for detecting prolonged theft and self-administration View source Failure to effectively review how deficient investigation reports gain executive approval View source Poor or absent clinical records View source Failure to identify the extent of gastrostomy leaks and onset of sepsis View source Unfit serious incident investigation reports View source See 6 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
David John Morris · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
David John Morris, aged 78, developed oesophageal cancer after delays in diagnosis and treatment, later undergoing gastrostomy surgery. He developed a gastrostomy leak, peritonitis and septic shock, and died in hospital on 16 May 2022 after further surgery. The concerns included delayed recognition and treatment of the leak and sepsis, poor clinical records, deficiencies in the investigation, and ineffective controlled-drug management systems.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Poor communication in cancer diagnosis and treatment
Wider context from the report “1. Mr Morris’s diagnosis and treatment for cancer was delayed due to poor organisation and communication at the Trust .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of serious incident investigations to identify relevant reviewing clinicians
Wider context from the report “4. The initial serious investigation report into Mr Morris’s death was unfit for purpose. The report to investigate or even identify the Registrar who reviewed Mr Morris on the evening of 3rd May 2022 . Since then, no effective review has been undertaken by the Trust upon how this deficient report gained executive approval.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to treat and escalate suspected sepsis promptly
Wider context from the report “2. During the evening of 3rd May 2022 going into the early hours of 4th May 2022, Doctors and nurses failed to identify the extent of Mr Morris’s gastrostomy leak and the onset of sepsis. After identifying symptoms of sepsis, staff failed to treat and escalate Mr Morris’s case resulting in a delay of three and a half hours before a medical review commenced emergency treatment .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Poor organisation of cancer diagnosis and treatment
Wider context from the report “1. Mr Morris’s diagnosis and treatment for cancer was delayed due to poor organisation and communication at the Trust.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Ineffective controlled drug management systems for detecting prolonged theft and self-administration
Wider context from the report “5. The Trust did not have effective controlled drug management systems in place to detect a prolonged and persistent course of conduct from an employed nurse who was stealing and self- administering controlled drugs in the workplace .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to effectively review how deficient investigation reports gain executive approval
Wider context from the report “4. The initial serious investigation report into Mr Morris’s death was unfit for purpose. The report to investigate or even identify the Registrar who reviewed Mr Morris on the evening of 3rd May 2022. Since then, no effective review has been undertaken by the Trust upon how this deficient report gained executive approval .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Poor or absent clinical records
Wider context from the report “3. During Mr Morris’s ward-based treatment on 3 & 4th May 2022 clinical records were either of a poor standard or were non-existent . The absence of clear records impeded the effective investigation of this death by the Trust’s governance teams and the Coroner.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to identify the extent of gastrostomy leaks and onset of sepsis
Wider context from the report “2. During the evening of 3rd May 2022 going into the early hours of 4th May 2022, Doctors and nurses failed to identify the extent of Mr Morris’s gastrostomy leak and the onset of sepsis . After identifying symptoms of sepsis, staff failed to treat and escalate Mr Morris’s case resulting in a delay of three and a half hours before a medical review commenced emergency treatment.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unfit serious incident investigation reports
Wider context from the report “4. The initial serious investigation report into Mr Morris’s death was unfit for purpose . The report to investigate or even identify the Registrar who reviewed Mr Morris on the evening of 3rd May 2022. Since then, no effective review has been undertaken by the Trust upon how this deficient report gained executive approval.
” Open source report
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The specific device instructions cannot be reviewed without the gastrostomy device’s brand and manufacturer.
Verbatim wording from the response “Without information regarding the specific brand and manufacturer of the gastrostomy device within the Regulation 28 report the MHRA have not been able to review the specific Instructions for Use (IFU) for the product, however, in general gastrostomy devices do include warnings regarding checking for leaks and stopping treatments and potentially replacing the” Source location 2024-0360 - Response from MHRA
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The removed gastrostomy device appeared functional, so no particular device fault appears to require regulatory action.
Verbatim wording from the response “device if leaks do occur. Additionally, it is stated that the device was removed and tested and appeared functional, therefore there does not appear to be a particular fault with the device that would be within the remit of the MHRA to address.” Source location 2024-0360 - Response from MHRA
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Medical advice and guidance on medical practice or care quality fall outside the respondent’s remit.
Verbatim wording from the response “The MHRA assesses the balance of risks and benefits of medical devices throughout their use in clinical practice through the collection of information and assessment of any potential risks, followed, when necessary, with communications and regulatory action to minimise those risks. The MHRA does not have a role in providing medical advice or guidance relating to medical practice or care quality and therefore cannot comment on those aspects of this case.” Source location 2024-0360 - Response from MHRA
Open published response
4 Jul 2024 Harry Peter DUNN · Prevention of Future Deaths report Northamptonshire
View report summary
Concerns raised 1 Unavailability of nasal or buccal analgesics to paramedics View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Harry Peter DUNN · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Harry Peter Dunn, aged 19, died shortly after arriving at hospital following a head-on collision between his motorcycle and a car on 27 August 2019. The report raises concern that paramedics cannot access nasal or buccal analgesics that may assist with potentially lifesaving pre-hospital treatment or faster patient extraction when time is critical.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Unavailability of nasal or buccal analgesics to paramedics
Wider context from the report “(1) As a result of the collision Mr Dunn landed in a prone position (on his front). In order for him to be treated by the pre hospital team he had to be moved out of this position to give ready access to his injuries. This necessitated the administration of analgesia. However, due to his positioning and the location of his injuries in conjunction with the extent of blood loss intravenous analgesics could not be administered.
(2) Due to the experience level and qualifications of the pre hospital team in attendance, which included a Consultant Anaesthetist, an alternative form of analgesia, namely nasal morphine could be administered.
(3) However, evidence was heard at the inquest that had the first attending team been a paramedic team they could not have administered this potentially lifesaving treatment as analgesia’s which can be delivered either nasally or buccally (via the cheek) are not presently available to paramedics despite being available to UK military personnel and mountain rescue teams.
(4) I am concerned that the unavailability of such analgesics to paramedics to assist them to deliver potentially life saving pre hospital treatments or to enable a faster extraction of a patient where time is of the essence for medical treatment reflects a risk of deaths into the future .
” Open source report
2 Jun 2024 Sewa Kaur Chaddha · Prevention of Future Deaths report Berkshire
View report summary
Concerns raised 2 Failure to adequately differentiate dosset boxes for elderly or cognitively impaired patients living at the same address View source Lack of disseminated guidance for pharmacists issuing medication to patients with cognitive impairments View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Sewa Kaur Chaddha · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Sewa Kaur Chaddha was found collapsed at home after taking her husband’s medication instead of her own for several days, including diabetes medication. She died in hospital from hyponatraemia caused by treatment for hypoglycaemia resulting from the accidental ingestion of hypoglycaemic medication. Concerns included the identical appearance of the couple’s dosset boxes, small patient-name labels, and the absence or poor dissemination of guidance for pharmacists supplying medication to people with cognitive impairment.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to adequately differentiate dosset boxes for elderly or cognitively impaired patients living at the same address
Wider context from the report “1) The medications were provided to the couple by the local pharmacy, then known as Lloyds Pharmacy, in separate dosset boxes. Mrs Chaddha’s medications were provided on a weekly basis. Mr Chaddha’s were provided on a monthly basis.
(2) Both patients were elderly and had cognitive impairment.
(3) The two patients’ dosset boxes were identical to each other except for a small pharmacist’s label with small type with the relevant patient’s name.
(4) Mrs Chaddha used one of Mr Chaddha’s dosset boxes, rather than her own, for several days.
(5) Evidence was given at the inquest that there was no guidance or policy in place for Pharmacists to follow when issuing medication to patients with cognitive impairments, or if there was, it was not well disseminated among the pharmacist population.
(6) Evidence was given at the inquest that dosset boxes of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of disseminated guidance for pharmacists issuing medication to patients with cognitive impairments
Wider context from the report “1) The medications were provided to the couple by the local pharmacy, then known as Lloyds Pharmacy, in separate dosset boxes. Mrs Chaddha’s medications were provided on a weekly basis. Mr Chaddha’s were provided on a monthly basis.
(2) Both patients were elderly and had cognitive impairment.
(3) The two patients’ dosset boxes were identical to each other except for a small pharmacist’s label with small type with the relevant patient’s name.
(4) Mrs Chaddha used one of Mr Chaddha’s dosset boxes, rather than her own, for several days.
(5) Evidence was given at the inquest that there was no guidance or policy in place for Pharmacists to follow when issuing medication to patients with cognitive impairments , or if there was, it was not well disseminated among the pharmacist population.
(6) Evidence was given at the inquest that dosset boxes of different colours or labels with different colours were not routinely given to elderly or cognitively impaired patients living at the same address.
” Open source report
12 Mar 2024 Jason Brown · Prevention of Future Deaths report Sunderland
View report summary
Concerns raised 1 Failure to prevent full-pack dispensing of Zuclopenthixol to patients prescribed weekly doses with suicidal risk and previous overdose attempts View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Jason Brown · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Jason Brown died at his home on 6 September 2022 after taking an overdose of his prescribed medication; the inquest concluded suicide, with the medical cause recorded as cardiac arrhythmia and drug overdose. The report raises concern that original-pack dispensing requirements for Zuclopenthixol dihydrochloride could provide a patient with suicidal risk and previous overdose attempts with a large quantity of medication.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to prevent full-pack dispensing of Zuclopenthixol to patients prescribed weekly doses with suicidal risk and previous overdose attempts
Wider context from the report “At the Inquest I heard evidence that prior to his death on 6th September 2022, Jason Brown received from the pharmacy his prescribed medication in a form of a full pack of ████████ tablets of Zuclopenthixol dihydrochloride (clopixol). The pharmacy confirmed in evidence that this had been dispensed as a full pack in accordance with its special container status. Jason was prescribed his medication in weekly doses due to a history which included previous attempts to take an overdose of his medication. Jason received this full pack of tablets only 17 days before taking an overdose of this medication on 6th September 2022. The pharmacy also confirmed that another patient at the practice received the same medication in a 7-day monitored dosage system (MDS) but could not confirm whether the remaining pack was then disposed of for that patient.
I am concerned that, due to a special container status, a box of ████████ tablets of Zuclopenthixol dihydrochloride (clopixol) must be dispensed in its own special container as a full pack of ████████ tablets (original pack dispensing) and that this can endanger the safety of a patient with a history of suicidal risk and previous overdose attempts.
Deaths may be prevented if the original pack dispensing guidance was reviewed for this medication.
” Open source report
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Responsibility for action on the Prevention of Future Deaths report rests with the General Pharmaceutical Council, whose response closes the regulatory review.
Verbatim wording from the response “Patient safety is our top priority, and we carefully consider the findings of all Prevention of Future Death reports. The General Pharmaceutical Council (GPhC) is responsible for action for the Prevention of Future Deaths, and I can confirm that the response led by the GPhC also closes the Medicines and Healthcare products Regulatory Agency review. The GPhC led on the response to the report, shared on 7 May 2024, for which we support the response.” Source location Response from MHRA
Open published response
Concerns raised 2 Failure of clozapine packaging and leaflets to warn that combined use with alcohol may cause death View source Lack of guidance on the risk of death from combined clozapine and alcohol use View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Sean Benjamin CRAWFORD · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Sean Benjamin CRAWFORD died on 18 December 2020 in Darlington from the combined toxic effect of alcohol and clozapine, neither being individually at toxic levels. The principal concern was that available guidance and medication packaging warned about alcohol, sedation and potentially dangerous side effects but did not advise that death could result from this combination.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of clozapine packaging and leaflets to warn that combined use with alcohol may cause death
Wider context from the report “The circumstances in which Sean came by his death, the combined effects of clozapine with alcohol, seems to be, statistically, very rare. None of the professionals who gave evidence in this case could cite a death with the same cause of death as that suffered by Sean. This said, clozapine is a well-established medication whose side effects are well known. It was originally developed in the 1960s. It is well-known that it requires careful management and monitoring. The side effects are recognised ones and widely known. None of the professional witnesses expressed any lack of familiarity with it or its side effects. One of these side effects is sedation. Likewise, obviously, alcohol is a recognised central nervous system depressant. This is a death from Central Nervous System Depression, consequent to a comparatively high level of clozapine and a comparatively high level of ethanol in the blood – neither individually fatal. It is evident that there is no guidance in any academic literature, British National Formulary, or NICE or MHRA advices on the dangers of death in this scenario. It is noticeable that the leaflet that comes with the Clozaril (clozapine) packages clearly states that it must not be taken with alcohol , and the evidence to me was that the medication comes with a further label, in a similar vein, on the packaging. Neither, however, advises of death being a possibility. All the literature advises that sedation is a potentially dangerous side effect of clozapine. Death from Central Nervous System Depression, over-sedation, is not uncommon. It is often associated with alcohol, and other substance, use.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of guidance on the risk of death from combined clozapine and alcohol use
Wider context from the report “The circumstances in which Sean came by his death, the combined effects of clozapine with alcohol, seems to be, statistically, very rare. None of the professionals who gave evidence in this case could cite a death with the same cause of death as that suffered by Sean. This said, clozapine is a well-established medication whose side effects are well known. It was originally developed in the 1960s. It is well-known that it requires careful management and monitoring. The side effects are recognised ones and widely known. None of the professional witnesses expressed any lack of familiarity with it or its side effects. One of these side effects is sedation. Likewise, obviously, alcohol is a recognised central nervous system depressant. This is a death from Central Nervous System Depression, consequent to a comparatively high level of clozapine and a comparatively high level of ethanol in the blood – neither individually fatal. It is evident that there is no guidance in any academic literature, British National Formulary, or NICE or MHRA advices on the dangers of death in this scenario. It is noticeable that the leaflet that comes with the Clozaril (clozapine) packages clearly states that it must not be taken with alcohol, and the evidence to me was that the medication comes with a further label, in a similar vein, on the packaging. Neither, however, advises of death being a possibility. All the literature advises that sedation is a potentially dangerous side effect of clozapine. Death from Central Nervous System Depression, over-sedation, is not uncommon. It is often associated with alcohol, and other substance, use.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Work with the British National Formulary as the clozapine assessment progresses.
Verbatim wording from the response “We are aware that you have also written to the BNF, and we will work with them as our assessment progresses. In the meantime, we will continue to closely monitor the safety of clozapine, including cases of drug-drug interactions. Should any updates to the product information be required we will issue an article in our bulletin to healthcare professionals “Drug Safety Update” accordingly.” Source location Response from Medicine and Healthcare products Regulatory Agency
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Conduct a further assessment of clozapine product information on drug-drug interactions and consider improvements for healthcare professionals, patients, families and carers.
Verbatim wording from the response “We have considered the evidence provided and the circumstances leading to Mr Crawford’s death. We have also recently met with a member of Mr Crawford’s immediate family to discuss their concerns. Some of these relate to clinical discussions between a patient and their prescriber which we are not able to address, as it is not within our remit to comment on the clinical care in specific cases. However, because of the nature of some of the concerns raised, we intend to conduct a further assessment of the information provided within the clozapine product information regarding drug-drug interactions. As part of this assessment, we will be giving careful consideration to the information which is provided to healthcare professionals, patients and their families and carers, and whether this can be improved.” Source location Response from Medicine and Healthcare products Regulatory Agency
Open published response
8 Dec 2023 Charlene Roberts · Prevention of Future Deaths report Manchester North
View report summary
Concerns raised 4 Failure to enforce pharmacy questioning and pharmacist presence for over-the-counter cyclizine purchases View source Lack of professional understanding of using the Controlled Drugs local intelligence network for non-controlled drugs View source Absence of a commissioned pathway for GPs to refer compromised community patients requiring blood tests View source Failure to consider cyclizine addiction in eating disorder services View source See 1 more concern
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Charlene Roberts · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Charlene Roberts died at Fairfield General Hospital on 12 January 2023 after suffering cardiac arrest during an inpatient admission; her cause of death was confirmed as cyclizine toxicity, with aspiration pneumonia, anorexia and factitious disorder also recorded. The principal concerns included the availability and prescribing of cyclizine, limited professional understanding of cyclizine dependence and the use of local intelligence systems for non-controlled drugs, and the lack of a commissioned community pathway for obtaining blood samples from compromised patients.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to enforce pharmacy questioning and pharmacist presence for over-the-counter cyclizine purchases
Wider context from the report “The court heard evidence that intravenous cyclizine is by prescription only but oral cyclizine can be purchased over the counter at a pharmacy. In order to purchase oral cyclizine in a pharmacy a pharmacist should seek information as to why it is required and should be present . Charlene’s family gave evidence that following Charlene’s death they had been able to obtain cyclizine in a pharmacy directly from a pharmacy assistant with no questions being asked of them .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of professional understanding of using the Controlled Drugs local intelligence network for non-controlled drugs
Wider context from the report “Cyclizine is not a controlled drug. At one stage consideration was given to using the Controlled Drugs local intelligence network as convened by NHS England (Controlled Drugs (Supervision and Management of Use) Regulations 2013) to put an alert out to local pharmacies to warn them about Charlene’s purchasing of cyclizine.
From the evidence there was a lack of clarity and understanding from professionals as to whether this local network could be used for drugs which are not controlled drugs . The fact that the legislation refers to controlled drugs may mean there is a lack of understanding about using this for system for non controlled drugs such as cyclizine.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Absence of a commissioned pathway for GPs to refer compromised community patients requiring blood tests
Wider context from the report “During the course of the evidence the court heard evidence from the GP who was responsible for obtaining weekly bloods to monitor her eating disorder. There is no commissioned pathway in Rochdale for GPs to refer patients who require bloods but who are compromised and therefore hard to obtain blood from . As a result patients are attending A&E departments for these to be taken .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to consider cyclizine addiction in eating disorder services
Wider context from the report “The court was made aware of the research conducted in 2009 as published in the journal PNS, “Proceedings of the Nutrition Society”, “Cyclizine dependence in patients with complex nutritional requirements” Thursby-Pelham, De Silva, Stroud and Fine, 23 July 2009. This identified cyclizine dependence in four female patients who all had complex nutritional problems.
Whilst it is acknowledged that this is one study and as stated cyclizine addiction is rare, it was not something which had been considered before Charlene’s addiction by the Eating Disorder Service . For the Manchester Eating Disorder Service there is now a greater awareness of cyclizine. This may be important nationally given its use as an anti-emetic.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review cyclizine safety, including misuse evidence and this case, to determine whether current risk-minimisation measures remain sufficient.
Verbatim wording from the response “The MHRA keeps the safe and effective use of medicines, including cyclizine, under continual review. We will consider the case raised in this report as well as wider evidence regarding the misuse of cyclizine and determine whether the current risk minimisation measures are sufficient. If further action is required, we will communicate this to healthcare professionals and patients.” Source location Response from MHRA
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Concerns about pharmacy information and patient consultation should be raised with the GPhC or CQC, which regulate relevant services.
Verbatim wording from the response “While we work closely with healthcare system partners, clinical practice is not within the remit of the MHRA. We would consider that concerns regarding the information provided by the pharmacy when patients request to purchase cyclizine without a prescription, and any consultation patients should receive, would be relevant to raise with the General Pharmaceutical Council, or GPhC, who are responsible for the regulation of the pharmacy profession, or the Care Quality Commission, or CQC, who regulate health and social care in the UK.” Source location Response from MHRA
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Clinical practice, including pharmacy information and patient consultation, is outside the respondent’s remit.
Verbatim wording from the response “While we work closely with healthcare system partners, clinical practice is not within the remit of the MHRA. We would consider that concerns regarding the information provided by the pharmacy when patients request to purchase cyclizine without a prescription, and any consultation patients should receive, would be relevant to raise with the General Pharmaceutical Council, or GPhC, who are responsible for the regulation of the pharmacy profession, or the Care Quality Commission, or CQC, who regulate health and social care in the UK.” Source location Response from MHRA
Open published response
25 Oct 2023 Federica Cavenati · Prevention of Future Deaths report Inner West London
View report summary
Concerns raised 1 Absence of intravenous anti-depressant medication for people unable to take medication orally View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Federica Cavenati · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Federica Cavenati died on 18 October 2021 after sustaining multiple traumatic injuries from a fall from height while receiving treatment at Chelsea and Westminster Hospital. The report identified contributing service-delivery issues including the absence of recent mental health review, removal of 1:1 mental health observations, and inconsistent antidepressant medication. A substantive concern was the absence in the United Kingdom of intravenous antidepressant medication for patients unable to take it orally for physical reasons.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Absence of intravenous anti-depressant medication for people unable to take medication orally
Wider context from the report “The absence of intravenous anti-depressant medication for those in need, who cannot for physical reasons take the medication orally. The evidence I heard confirmed the existence of intravenous anti-depressants in Europe but not in the United Kingdom.
” Open source report
17 Aug 2023 Shirley Frances Ashelford · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 6 Failure to provide inspectors with information about recent hoist problems View source Lack of service-provider awareness of positional asphyxia risks during hoisting View source Lack of user and carer awareness of positional asphyxia risks during hoisting View source Failure to train carers in emergency lowering using the hoist red cord View source Possible design fault in hoist lowering function View source Failure of OT and AMT to share information about hoist condition View source See 3 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Shirley Frances Ashelford · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Shirley Frances Ashelford died after the lowering mechanism of a ceiling hoist failed while she was transferring from her bed to a mobility scooter, leaving her suspended in a chest harness. The harness tightened and, in combination with respiratory weakness caused by multiple sclerosis, led to fatal asphyxia. Concerns included inadequate awareness and training about positional asphyxia and emergency lowering, failures to share information about reported hoist problems, and a possible design fault in the hoist's lowering function.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to provide inspectors with information about recent hoist problems
Wider context from the report “5) I am concerned that the Bureau Veritas inspection report of 30/6/21 made no reference to the report of Higher Elevation and Shirley’s complaint on 9/4/21 indicating that the inspector was unaware of recent problems . Had they been aware they might have been able to detect the problem which caused the failure of the hoist to lower on the 20/7/21.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of service-provider awareness of positional asphyxia risks during hoisting
Wider context from the report “1) The risk of fatal positional asphyxia associated with the use of harnesses/slings when hoisting was not appreciated by the OT services and AMT concerned with the provision, use and maintenance of the hoist. This indicates that training may be required to raise awareness of the risk of positional asphyxia in order to reduce the risk of future deaths. I consider it important to highlight to service providers the dangers associated with unassisted use of ceiling hoists and sling harnesses.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of user and carer awareness of positional asphyxia risks during hoisting
Wider context from the report “2) Users and carers did not appear to have been made aware of the asphyxia risk associated with hoisting . It was not clear whether Shirley was trained in the use of the red cord safety feature on the hoist as there was no documentation to confirm this. Her husband and carer had never received training in the use of the red cord for emergency lowering. He was also unaware of the risks of positional asphyxia when Shirley was operating the hoist on her own . My concern is that there may be a general a lack of training of users and carers in the operation of this type of hoist and the risk of positional asphyxia.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to train carers in emergency lowering using the hoist red cord
Wider context from the report “2) Users and carers did not appear to have been made aware of the asphyxia risk associated with hoisting. It was not clear whether Shirley was trained in the use of the red cord safety feature on the hoist as there was no documentation to confirm this. Her husband and carer had never received training in the use of the red cord for emergency lowering . He was also unaware of the risks of positional asphyxia when Shirley was operating the hoist on her own. My concern is that there may be a general a lack of training of users and carers in the operation of this type of hoist and the risk of positional asphyxia.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Possible design fault in hoist lowering function
Wider context from the report “4) There was some evidence that another hoist of the same model in the bathroom had a problem with the lowering function and the possibility of a fault in the design of the lowering function . I raise this concern to alert the MHRA and Prism Medical UK Ltd in order to conduct appropriate safety investigations. The hoists are available in situ for a limited period or otherwise will be kept in storage by the Local Authority for inspection purposes.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medicines and Healthcare products Regulatory Agency; that does not assign responsibility.
PFD Monitor interpretation Failure of OT and AMT to share information about hoist condition
Wider context from the report “3) I am concerned that two departments in the local authority, the OT department and AMT, did not share information concerning the condition of the hoist , namely, Shirley’s reports to OT were not shared with AMT and visit reports from contractors to AMT were not shared with the OT . Likewise, the Bureau Veritas inspection on 30/6/21 appears to have occurred in an information vacuum regarding recent problems with the hoist. Whilst the Veritas inspection report was shared with the AMT it was not shared with the OT department.
” Open source report
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations