25 Feb 2014 Arthur Brockett-Deakins · Prevention of Future Deaths report Inner South London
View report summary
Concerns raised 8 Inadequate governance and oversight of private midwifery-led services across the mixed health economy View source Insufficient CTG interpretation training and competence View source Inconsistent thresholds for review and intervention between private and NHS maternity care View source Maternal pulse being displayed as fetal heart rate on CTG machines View source Unsafe staffing and shift arrangements for private midwifery services View source Failure to document and risk-assess private midwifery-led service arrangements View source Failure to escalate abnormal CTG findings appropriately in slow second-stage labour View source Insufficient specialist and interdisciplinary support for private midwifery-led services View source See 5 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
Arthur Brockett-Deakins · 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
Arthur Brockett-Deakins was born in poor condition on 16 December 2007 after complications during labour and suffered severe disabilities resulting from acute profound perinatal hypoxic-ischaemic encephalopathy. He died at home on 18 October 2011 from respiratory problems. The report identified concerns about failure to escalate an abnormal CTG, administration and monitoring of Syntocinon, CTG interpretation and display of the maternal heart rate, and the organisation and support of a private midwifery-led service.
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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 Inadequate governance and oversight of private midwifery-led services across the mixed health economy
Wider context from the report “4. Models of private midwifery led services for low risk pregnancy: The private midwifery caseload for low risk pregnancies was managed by a pair of midwives who set up the service to provide continuity of care. The midwife service that was operating when ████████ was pregnant was not adequately documented. No job description was seen by the court and the referral and operational arrangements were discussed, but no documentation was brought to the court. There was no evidence of risk assessment. Although NHS employees were required to be self sufficient in terms of annual leave and sickness cover, on call arrangements and use of NHS personnel except in emergencies. They did not at the outset have a link obstetrician. This led to fear of burn out, a sense of isolation and lack of support and collegiality.
When they transferred babies to the Hospital Birthing Centre, they were expected to refer to a duty obstetric consultant, access to whom was described as variable. The midwife in charge of the NHS unit agreed that she provided a different threshold of care to private and NHS mothers and was reluctant to intervene or review the care plan for augmentation of labour, which she would have done in an NHS patient. The midwives expected her to be involved but did not ask her. In the event no peer senior midwife or obstetrician saw ████████ which was necessary. The reasons for non referral were complex and were not because the midwives thought they could not refer. Misjudgements were made which in part were caused by a 15 hour shift with only a 40 minute break. This would not occur in contexts where there was normal NHS management of staff, but this arrangement continued apparently unknown to the NHS Trust management. The service is no longer operational, the Trust reporting that it was discontinued for economic reasons.
Expert advice considered that the model of service created a risk of deaths, although it was not found to have directly done so in this case. Dr ████████ reported that there were similar units operating elsewhere in the country and that the lessons from the difficulties in operating this one should be disseminated to other such units. The expert midwife, Ms ████████ was particularly concerned about adequate support and Dr. ████████ was particularly concerned about the isolation and professional culture and lack of interdisciplinary peer discussion, in the context of increasingly risks in obstetric and midwifery practice.
The Trust head midwife reported that she expected that the matter would now be dealt with robustly by the statutory supervision system. No evidence was heard about whether this was now effective in this regard , nor how influence and information could be brought to bear on those setting up or managing such midwife led services. It was further reported that not all midwives are members of the College that runs that supervision and that midwives are not necessarily practising within the NHS. Thus is it was not clear how the risks are best identified and managed across a complex mixed health economy , which is why the Secretary of State is an addressee of my report.
” 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 CTG interpretation training and competence
Wider context from the report “2. Training of one midwife in CTG interpretation: Both midwives underwent voluntary further training and supervision, including an expert workshop on CTG interpretation. Both accepted that a number of errors had been made by them and applied the learning to their current practice. However even in retrospect, one of the midwives could not accept that the early CTG trace was pathological , as held by both expert obstetrician and midwife. Although she would refer now, there is doubt about the urgency . She said in court it would be within half an hour but also that 40 minutes was needed to see if it was abnormal. The expert midwife said that she needed further training on CTG interpretation .
” 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 Inconsistent thresholds for review and intervention between private and NHS maternity care
Wider context from the report “4. Models of private midwifery led services for low risk pregnancy: The private midwifery caseload for low risk pregnancies was managed by a pair of midwives who set up the service to provide continuity of care. The midwife service that was operating when ████████ was pregnant was not adequately documented. No job description was seen by the court and the referral and operational arrangements were discussed, but no documentation was brought to the court. There was no evidence of risk assessment. Although NHS employees were required to be self sufficient in terms of annual leave and sickness cover, on call arrangements and use of NHS personnel except in emergencies. They did not at the outset have a link obstetrician. This led to fear of burn out, a sense of isolation and lack of support and collegiality.
When they transferred babies to the Hospital Birthing Centre, they were expected to refer to a duty obstetric consultant, access to whom was described as variable. The midwife in charge of the NHS unit agreed that she provided a different threshold of care to private and NHS mothers and was reluctant to intervene or review the care plan for augmentation of labour , which she would have done in an NHS patient. The midwives expected her to be involved but did not ask her. In the event no peer senior midwife or obstetrician saw ████████ which was necessary . The reasons for non referral were complex and were not because the midwives thought they could not refer. Misjudgements were made which in part were caused by a 15 hour shift with only a 40 minute break. This would not occur in contexts where there was normal NHS management of staff, but this arrangement continued apparently unknown to the NHS Trust management. The service is no longer operational, the Trust reporting that it was discontinued for economic reasons.
Expert advice considered that the model of service created a risk of deaths, although it was not found to have directly done so in this case. Dr ████████ reported that there were similar units operating elsewhere in the country and that the lessons from the difficulties in operating this one should be disseminated to other such units. The expert midwife, Ms ████████ was particularly concerned about adequate support and Dr. ████████ was particularly concerned about the isolation and professional culture and lack of interdisciplinary peer discussion, in the context of increasingly risks in obstetric and midwifery practice.
The Trust head midwife reported that she expected that the matter would now be dealt with robustly by the statutory supervision system. No evidence was heard about whether this was now effective in this regard, nor how influence and information could be brought to bear on those setting up or managing such midwife led services. It was further reported that not all midwives are members of the College that runs that supervision and that midwives are not necessarily practising within the NHS. Thus is it was not clear how the risks are best identified and managed across a complex mixed health economy, which is why the Secretary of State is an addressee of my report.
” 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 Maternal pulse being displayed as fetal heart rate on CTG machines
Wider context from the report “3. Display of MHR as FHR on CTGs: Ms ████████ explained that if the foetus moves out of the range of the ultrasound field or the baby has sadly died, the ultrasound transducer may then pick up the maternal pulse from the aorta, iliac or uterine artery and it is displayed as the FHR and can show reactivity and variability due to MHR changes and muscle contractions can be difficult to distinguish from the FHR. It is known that the rate can be doubled or halved .
The only explanation that both expert midwife and expert obstetrician could reach for the unusual CTG trace after 1pm, in the context of the state of the baby at birth, was that the maternal pulse rate was masquerading as the FHR but it had been multiplied by 1.5 . The CTG machine was not the type that is known rarely to multiply by 2 and the phenomenon of a multiplication by a factor other than 2, being unknown to both experts in their distinguished careers. Evidence was not heard from the manufacturer or the product's regulatory authority. The inquest heard that new CTG machines incorporate maternal ECG or pulse oximetry, which alerts staff to investigate when MHR and FHR appear the same. But it also heard that it will take some time before all old machines are replaced . It needs to be established if multiplying by 1.5 is a possible functional feature of some machines and if so whether either it can be designed away or whether dissemination or guidance or an action by the regulatory authority is needed to prevent it leading to a fatality or child disability.
” 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 Unsafe staffing and shift arrangements for private midwifery services
Wider context from the report “4. Models of private midwifery led services for low risk pregnancy: The private midwifery caseload for low risk pregnancies was managed by a pair of midwives who set up the service to provide continuity of care. The midwife service that was operating when ████████ was pregnant was not adequately documented. No job description was seen by the court and the referral and operational arrangements were discussed, but no documentation was brought to the court. There was no evidence of risk assessment. Although NHS employees were required to be self sufficient in terms of annual leave and sickness cover, on call arrangements and use of NHS personnel except in emergencies. They did not at the outset have a link obstetrician. This led to fear of burn out, a sense of isolation and lack of support and collegiality.
When they transferred babies to the Hospital Birthing Centre, they were expected to refer to a duty obstetric consultant, access to whom was described as variable. The midwife in charge of the NHS unit agreed that she provided a different threshold of care to private and NHS mothers and was reluctant to intervene or review the care plan for augmentation of labour, which she would have done in an NHS patient. The midwives expected her to be involved but did not ask her. In the event no peer senior midwife or obstetrician saw ████████ which was necessary. The reasons for non referral were complex and were not because the midwives thought they could not refer. Misjudgements were made which in part were caused by a 15 hour shift with only a 40 minute break . This would not occur in contexts where there was normal NHS management of staff, but this arrangement continued apparently unknown to the NHS Trust management. The service is no longer operational, the Trust reporting that it was discontinued for economic reasons.
Expert advice considered that the model of service created a risk of deaths, although it was not found to have directly done so in this case. Dr ████████ reported that there were similar units operating elsewhere in the country and that the lessons from the difficulties in operating this one should be disseminated to other such units. The expert midwife, Ms ████████ was particularly concerned about adequate support and Dr. ████████ was particularly concerned about the isolation and professional culture and lack of interdisciplinary peer discussion, in the context of increasingly risks in obstetric and midwifery practice.
The Trust head midwife reported that she expected that the matter would now be dealt with robustly by the statutory supervision system. No evidence was heard about whether this was now effective in this regard, nor how influence and information could be brought to bear on those setting up or managing such midwife led services. It was further reported that not all midwives are members of the College that runs that supervision and that midwives are not necessarily practising within the NHS. Thus is it was not clear how the risks are best identified and managed across a complex mixed health economy, which is why the Secretary of State is an addressee of my report.
” 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 document and risk-assess private midwifery-led service arrangements
Wider context from the report “4. Models of private midwifery led services for low risk pregnancy: The private midwifery caseload for low risk pregnancies was managed by a pair of midwives who set up the service to provide continuity of care. The midwife service that was operating when ████████ was pregnant was not adequately documented . No job description was seen by the court and the referral and operational arrangements were discussed, but no documentation was brought to the court . There was no evidence of risk assessment . Although NHS employees were required to be self sufficient in terms of annual leave and sickness cover, on call arrangements and use of NHS personnel except in emergencies. They did not at the outset have a link obstetrician. This led to fear of burn out, a sense of isolation and lack of support and collegiality.
When they transferred babies to the Hospital Birthing Centre, they were expected to refer to a duty obstetric consultant, access to whom was described as variable. The midwife in charge of the NHS unit agreed that she provided a different threshold of care to private and NHS mothers and was reluctant to intervene or review the care plan for augmentation of labour, which she would have done in an NHS patient. The midwives expected her to be involved but did not ask her. In the event no peer senior midwife or obstetrician saw ████████ which was necessary. The reasons for non referral were complex and were not because the midwives thought they could not refer. Misjudgements were made which in part were caused by a 15 hour shift with only a 40 minute break. This would not occur in contexts where there was normal NHS management of staff, but this arrangement continued apparently unknown to the NHS Trust management. The service is no longer operational, the Trust reporting that it was discontinued for economic reasons.
Expert advice considered that the model of service created a risk of deaths, although it was not found to have directly done so in this case. Dr ████████ reported that there were similar units operating elsewhere in the country and that the lessons from the difficulties in operating this one should be disseminated to other such units. The expert midwife, Ms ████████ was particularly concerned about adequate support and Dr. ████████ was particularly concerned about the isolation and professional culture and lack of interdisciplinary peer discussion, in the context of increasingly risks in obstetric and midwifery practice.
The Trust head midwife reported that she expected that the matter would now be dealt with robustly by the statutory supervision system. No evidence was heard about whether this was now effective in this regard, nor how influence and information could be brought to bear on those setting up or managing such midwife led services. It was further reported that not all midwives are members of the College that runs that supervision and that midwives are not necessarily practising within the NHS. Thus is it was not clear how the risks are best identified and managed across a complex mixed health economy, which is why the Secretary of State is an addressee of my report.
” 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 escalate abnormal CTG findings appropriately in slow second-stage labour
Wider context from the report “1. When to escalate concerns about a CTG: With regard to not escalating an abnormal CTG that ran for about half an hour after augmentation of labour, reliance was placed by midwives on a clause of NICE Clinical Guidelines, Intrapartum Care, 2007, which advises that a 40 minutes trace should be studied before concluding if it is abnormal. Expert evidence from Dr ████████ and Ms ████████ suggested that this guidance was appropriate in the first stage of labour, but not in the context in this case, namely a slow second stage .
” 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 specialist and interdisciplinary support for private midwifery-led services
Wider context from the report “4. Models of private midwifery led services for low risk pregnancy: The private midwifery caseload for low risk pregnancies was managed by a pair of midwives who set up the service to provide continuity of care. The midwife service that was operating when ████████ was pregnant was not adequately documented. No job description was seen by the court and the referral and operational arrangements were discussed, but no documentation was brought to the court. There was no evidence of risk assessment. Although NHS employees were required to be self sufficient in terms of annual leave and sickness cover, on call arrangements and use of NHS personnel except in emergencies. They did not at the outset have a link obstetrician . This led to fear of burn out, a sense of isolation and lack of support and collegiality.
When they transferred babies to the Hospital Birthing Centre, they were expected to refer to a duty obstetric consultant, access to whom was described as variable . The midwife in charge of the NHS unit agreed that she provided a different threshold of care to private and NHS mothers and was reluctant to intervene or review the care plan for augmentation of labour, which she would have done in an NHS patient. The midwives expected her to be involved but did not ask her. In the event no peer senior midwife or obstetrician saw ████████ which was necessary. The reasons for non referral were complex and were not because the midwives thought they could not refer. Misjudgements were made which in part were caused by a 15 hour shift with only a 40 minute break. This would not occur in contexts where there was normal NHS management of staff, but this arrangement continued apparently unknown to the NHS Trust management. The service is no longer operational, the Trust reporting that it was discontinued for economic reasons.
Expert advice considered that the model of service created a risk of deaths, although it was not found to have directly done so in this case. Dr ████████ reported that there were similar units operating elsewhere in the country and that the lessons from the difficulties in operating this one should be disseminated to other such units. The expert midwife, Ms ████████ was particularly concerned about adequate support and Dr. ████████ was particularly concerned about the isolation and professional culture and lack of interdisciplinary peer discussion , in the context of increasingly risks in obstetric and midwifery practice.
The Trust head midwife reported that she expected that the matter would now be dealt with robustly by the statutory supervision system. No evidence was heard about whether this was now effective in this regard, nor how influence and information could be brought to bear on those setting up or managing such midwife led services. It was further reported that not all midwives are members of the College that runs that supervision and that midwives are not necessarily practising within the NHS. Thus is it was not clear how the risks are best identified and managed across a complex mixed health economy, which is why the Secretary of State is an addressee of my report.
” 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 Revise CTG-use safety advice and issue current guidance as MDA 2010/054.
Verbatim wording from the response “Our advice on CTG use was revised in 2010 to become MDA 2010/054, and is our current advice.” Source location 2014-0077-Response-by-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 Publish a maternity edition of One Liners highlighting issues in interpreting CTG readings.
Verbatim wording from the response “In June 2013, MHRA published a special maternity edition of ‘One Liners’, which again highlighted the issues of interpreting CTG readings.” Source location 2014-0077-Response-by-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 Publish and disseminate safety advice warning healthcare professionals about risks in interpreting CTG traces.
Verbatim wording from the response “One of our predecessor Agencies, The Medical Devices Agency (MDA), published and disseminated a Safety Notice to relevant healthcare professionals in August 2002, warning of the risks associated with the interpretation of CTG traces. This Safety Notice, MDA SN2002(23), was extant in 2007 and a copy is appended to this letter.” Source location 2014-0077-Response-by-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 Insufficient user and manufacturer evidence prevents advising that older CTG units should be removed from clinical use.
Verbatim wording from the response “Modern CTG units now incorporate maternal ECG or pulse oximetry functions and many have prompts to double-check if readings of MHR x 2 occur. It is possible that some older units remain in clinical use but there is insufficient evidence provided by users and manufacturers for MHRA to advise that they should be removed from use.” Source location 2014-0077-Response-by-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 Existing CTG safety advice and related communications are considered appropriate for those using CTG medical devices.
Verbatim wording from the response “Our advice on CTG use was revised in 2010 to become MDA 2010/054, and is our current advice.” Source location 2014-0077-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Open published response
31 Jan 2014 William George KENT · Prevention of Future Deaths report Surrey
View report summary
Concerns raised 4 Lack of clarity on the use of Haz-Tab granules in clinical spillages View source Lack of awareness of Haz-Tab granules’ potentially harmful side-effects for urine spillages View source Under-emphasis of hazardous consequences from noxious gas release when Haz-Tab granules contact urine View source Limited teaching of cleaning products’ side-effects during staff induction and mandatory infection control updates 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.
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AI-generated summary
William George KENT · 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 George KENT was admitted to hospital after a fall and later developed acute respiratory distress after Haz-Tab granules were used on urine near his bed. He was transferred for further treatment but died after chlorine inhalation was identified as a significant contributing trigger. Concerns included insufficient awareness and training about the hazards and appropriate use of Haz-Tab granules, including the release of noxious gases when they contact urine.
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 clarity on the use of Haz-Tab granules in clinical spillages
Wider context from the report “3. Lack of clarity on how Haz-Tab granules should be used in clinical spillages
” 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 awareness of Haz-Tab granules’ potentially harmful side-effects for urine spillages
Wider context from the report “1. Lack of awareness of the potentially harmful side-effects of Haz-Tab granules for urine spillages
” 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 Under-emphasis of hazardous consequences from noxious gas release when Haz-Tab granules contact urine
Wider context from the report “4. An under-emphasis of the potential hazardous consequences from the release of noxious gases when Haz-Tab granules are in contact with urine (with or without contamination of blood)
” 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 teaching of cleaning products’ side-effects during staff induction and mandatory infection control updates
Wider context from the report “2. Limited time given over to the teaching of the side-effects of cleaning products such as Haz-Tab granules at the induction of new staff and at yearly mandatory infection control updates
” Open source report
14 Jan 2014 Craig Adam White · Prevention of Future Deaths report South Lincolnshire
View report summary
Concerns raised 4 Failure to provide continuing patient education about Infliximab treatment risks View source Delays in initiating treatment when tuberculous meningitis is suspected View source Lack of protocols for pre-Infliximab tuberculosis screening View source Lack of healthcare professional awareness of the increased tuberculosis risk inherent in Infliximab treatment 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
Craig Adam White · 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
Craig Adam White was a 21-year-old student who developed disseminated tuberculosis, including tuberculosis leptomeningitis, while receiving immunosuppressive treatment for Crohn’s disease. He had recurrent chest infections and later deteriorated with neurological illness before tuberculosis was confirmed. The principal concerns were tuberculosis screening before Infliximab treatment, healthcare professionals’ awareness of the associated risk, continuing patient education, and prompt treatment when tuberculous meningitis is suspected.
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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 provide continuing patient education about Infliximab treatment risks
Wider context from the report “3 The need for continuing patient education about the risks of Infliximab 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 Delays in initiating treatment when tuberculous meningitis is suspected
Wider context from the report “4 The need for prompt treatment to be initiated when tuberculous meningitis is suspected
” 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 protocols for pre-Infliximab tuberculosis screening
Wider context from the report “1 Protocols for pre-Infliximab treatment screening for tuberculosis
” 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 healthcare professional awareness of the increased tuberculosis risk inherent in Infliximab treatment
Wider context from the report “2 Awareness of Health Care Professionals, in particular prescribers of the increased risk of TB inherent Infliximab treatment
” Open source report
19 Dec 2013 Kenneth Smalley · Prevention of Future Deaths report Manchester West
View report summary
Concerns raised 6 Handset emergency stop buttons failing to operate independently when other handset parts are damaged View source Inadequate staff training and auditing of pre-operative equipment checks View source Pre-operation checks failing to assess handset function, condition, seals and position View source Inspection procedures failing to identify handset damage and secure immediate replacement View source Failure to share investigation information with interested agencies promptly View source Failure to review operating tables and handsets used at the Hospital 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
Kenneth Smalley · 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
Kenneth Smalley died after surgery to remove an infected aortic graft and repair an aortoduodenal fistula. During the surgery, an operating table moved uncontrollably and its emergency stop button did not work; later, bleeding from splenic lacerations required a splenectomy, and he deteriorated and died. Concerns included the safety, inspection, maintenance, positioning and checking of operating-table handsets, staff training and auditing, and the sharing of investigation findings between relevant organisations.
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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 Handset emergency stop buttons failing to operate independently when other handset parts are damaged
Wider context from the report “(3) I have concerns with regard to the Eschmann Group in relation to a review of the operation of handsets attached to operating tables in view of the number of unexplained and uncontrolled movements of operating tables with particular reference to the isolation of the emergency stop button on the handsets to ensure that the emergency stop button operates in all circumstances when there is damage to other parts of the handset .
” 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 staff training and auditing of pre-operative equipment checks
Wider context from the report “(2) I have concerns with regard to the Wrightington, Wigan & Leigh NHS Foundation Trust in relation to
i) The function of operating tables and handsets particularly the review of all operating tables and handsets used at the Hospital following the incident on the 27th March 2013.
ii) Pre-operation checks of equipment particularly the function of handsets attached to operating tables with particular attention to the general condition of the handsets, the seals, and the position of the handsets at the side of the operating table to avoid the handsets being placed on the floor of the Operating Theatre to reduce the risk of fluid ingress.
iii) The procedures relating to inspection of operating tables and handsets used at the Hospital particularly to identify any damage to the handsets to ensure the immediate replacement of any damaged handsets.
iv) The training of staff in relation to pre-operative checks of equipment in the operating theatres at the Hospital with emphasis on operating tables and handsets including the correct positioning of the handsets with effective auditing of such inspections .
” 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 Pre-operation checks failing to assess handset function, condition, seals and position
Wider context from the report “(2) I have concerns with regard to the Wrightington, Wigan & Leigh NHS Foundation Trust in relation to
i) The function of operating tables and handsets particularly the review of all operating tables and handsets used at the Hospital following the incident on the 27th March 2013.
ii) Pre-operation checks of equipment particularly the function of handsets attached to operating tables with particular attention to the general condition of the handsets, the seals, and the position of the handsets at the side of the operating table to avoid the handsets being placed on the floor of the Operating Theatre to reduce the risk of fluid ingress.
iii) The procedures relating to inspection of operating tables and handsets used at the Hospital particularly to identify any damage to the handsets to ensure the immediate replacement of any damaged handsets.
iv) The training of staff in relation to pre-operative checks of equipment in the operating theatres at the Hospital with emphasis on operating tables and handsets including the correct positioning of the handsets with effective auditing of such inspections.
” 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 Inspection procedures failing to identify handset damage and secure immediate replacement
Wider context from the report “(2) I have concerns with regard to the Wrightington, Wigan & Leigh NHS Foundation Trust in relation to
i) The function of operating tables and handsets particularly the review of all operating tables and handsets used at the Hospital following the incident on the 27th March 2013.
ii) Pre-operation checks of equipment particularly the function of handsets attached to operating tables with particular attention to the general condition of the handsets, the seals, and the position of the handsets at the side of the operating table to avoid the handsets being placed on the floor of the Operating Theatre to reduce the risk of fluid ingress.
iii) The procedures relating to inspection of operating tables and handsets used at the Hospital particularly to identify any damage to the handsets to ensure the immediate replacement of any damaged handsets .
iv) The training of staff in relation to pre-operative checks of equipment in the operating theatres at the Hospital with emphasis on operating tables and handsets including the correct positioning of the handsets with effective auditing of such inspections.
” 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 share investigation information with interested agencies promptly
Wider context from the report “(4) I have concerns with regard to the Medicines and Healthcare Products Regulatory Agency in relation to contact with all interested Agencies following an investigation to ensure the sharing of information with all interested Agencies particularly to enable lessons to be learned and corrective action to be taken as soon as possible .
” 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 review operating tables and handsets used at the Hospital
Wider context from the report “(2) I have concerns with regard to the Wrightington, Wigan & Leigh NHS Foundation Trust in relation to
i) The function of operating tables and handsets particularly the review of all operating tables and handsets used at the Hospital following the incident on the 27th March 2013.
ii) Pre-operation checks of equipment particularly the function of handsets attached to operating tables with particular attention to the general condition of the handsets, the seals, and the position of the handsets at the side of the operating table to avoid the handsets being placed on the floor of the Operating Theatre to reduce the risk of fluid ingress.
iii) The procedures relating to inspection of operating tables and handsets used at the Hospital particularly to identify any damage to the handsets to ensure the immediate replacement of any damaged handsets.
iv) The training of staff in relation to pre-operative checks of equipment in the operating theatres at the Hospital with emphasis on operating tables and handsets including the correct positioning of the handsets with effective auditing of such inspections.
” 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