27 Feb 2026 David James FENN · Prevention of Future Deaths report Essex
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Concerns raised 2
Failure to follow the Sepsis 6 Pathway View source Failure to appropriately recognise signs of sepsis View source
This report raised 6 other concerns. They are not shown here because they do not form part of this recurring concern.
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David James FENN · 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 James FENN was admitted to hospital with suspected sepsis and septic left knee arthritis, after attending several days earlier with similar symptoms and being discharged home. He subsequently developed severe sepsis and multiorgan failure and died on 12 February 2025. The principal concerns were that sepsis was not appropriately recognised on 28 January, the Sepsis 6 pathway was not followed, timely consultant review was not obtained, and relevant clinical discussions and escalation did not occur adequately.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to follow the Sepsis 6 Pathway
Wider context from the report “1) Signs of sepsis where not appropriately recognised and the Sepsis 6 Pathway was not followed .
” Source location David James FENN · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to appropriately recognise signs of sepsis
Wider context from the report “1) Signs of sepsis where not appropriately recognised and the Sepsis 6 Pathway was not followed.
” Source location David James FENN · Prevention of Future Deaths report
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Embed Sepsis 6 prompts, mandatory data fields, treatment-plan completion checks, senior notifications and monthly compliance monitoring within Epic.
Verbatim wording from the response “When a patient’s NEWS score is calculated as being above 2, the treating clinician needs to answer several sets of questions about the patient’s presentation, to determine whether the ‘sepsis 6 bundle’ should be commenced. The bundle should begin within 1 hour of recognition.” Source location Response from East Sussex and North Essex NHS Foundation Trust
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Deliver mandatory sepsis identification and action training through Trust induction and ongoing top-up sessions for staff across all wards and levels.
Verbatim wording from the response “The Trust has delivered and continues to deliver sepsis identification and action training for all staff on all wards and at all levels, as per Trust policy. The training is mandatory, forming part of all Trust inductions, with top up training sessions provided whenever there is a need.” Source location Response from East Sussex and North Essex NHS Foundation Trust
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13 Feb 2026 Edward Richard Jones · Prevention of Future Deaths report West Yorkshire Eastern
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Concerns raised 1
Absence of a validated and sufficiently discriminating sepsis screening tool for Paediatric Emergency Departments View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 2
NHS England
Roll out the National Paediatric Early Warning System with an integrated sepsis trigger for recognising deterioration in hospitalised children.
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NHS England
Trial an Emergency Department version of the National Paediatric Early Warning System.
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Edward Richard Jones · 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
Edward Richard Jones died from invasive Group A Streptococcus sepsis after presenting to the Paediatric Emergency Department with abdominal and leg pain, diarrhoea, previous vomiting and dehydration. The substantive concerns included failure to repeat a venous blood gas showing raised lactate, non-use of the trust’s Sepsis Screening Tool, delayed recognition and treatment of sepsis, and delays associated with communication, staffing and bed pressures.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Absence of a validated and sufficiently discriminating sepsis screening tool for Paediatric Emergency Departments
Wider context from the report “The inquest was told it is acknowledged nationally that there is no Sepsis Screening Tool which is validated for use in Paediatric Emergency Departments or has a sensitivity or specificity which makes it a useful tool for escalation within a Paediatric Emergency Department .
” Source location Edward Richard Jones · Prevention of Future Deaths report
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Roll out the National Paediatric Early Warning System with an integrated sepsis trigger for recognising deterioration in hospitalised children.
Verbatim wording from the response “NHS England rolled out the National Paediatric Early Warning System (NPEWS) in November 2023. The NPEWS is a national standardised approach of tracking the deterioration of children in hospital. The aim of the NPEWS is to allow for consistency in how deterioration in children is recognised. The NPEWS incorporates a sepsis trigger which encompasses the Academy of Medical Royal Colleges guidance. A sepsis trigger is a set of criteria, in this case the NPEWS ‘score’, which is used to trigger a review of a patient.” Source location 2026-0096 - Response from Medical Director NHS England
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Trial an Emergency Department version of the National Paediatric Early Warning System.
Verbatim wording from the response “The RCPH and NHS England are currently trialling an Emergency Department (ED) NPEWS, and this should be published this year. Both RCPCH and Royal College of Emergency Medicine (RCEM) fully support the introduction of ED NPEWS.” Source location 2026-0096 - Response from Medical Director NHS England
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation NHS England relies on NPEWS, including its sepsis trigger, rather than introducing a separate national paediatric emergency department sepsis screening tool.
Verbatim wording from the response “Your Report raises concerns that nationally there is no sepsis screening tool which is validated for use in Paediatric Emergency Departments. You highlighted that Leeds Teaching Hospital Trust have developed a local sepsis screening tool.” Source location 2026-0096 - Response from Medical Director NHS England
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18 Dec 2025 Edward Richard Jones · Prevention of Future Deaths report West Yorkshire Eastern
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Concerns raised 2
Absence of a validated and sufficiently discriminating sepsis screening tool for escalation in Paediatric Emergency Departments View source Failure to consistently deploy the Sepsis Screening Tool across Paediatric Emergency and paediatric in-patient settings View source
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AI-generated summary
Edward Richard Jones · 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
Edward Richard Jones died in the Leeds General Infirmary from bacterial sepsis caused by invasive Group A Streptococcus. The inquest identified concerns including failure to respond adequately to a continuously high PAWS score, failure to repeat a venous blood gas showing raised lactate, and delay in administering antibiotics. The hospital trust’s Sepsis Screening Tool was not used, and staffing and bed shortages prolonged shared care in the Paediatric Emergency Department.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Absence of a validated and sufficiently discriminating sepsis screening tool for escalation in Paediatric Emergency Departments
Wider context from the report “The inquest was told it is acknowledged nationally that there is no Sepsis Screening Tool which is validated for use in Paediatric Emergency Departments or has a sensitivity or specificity which makes it a useful tool for escalation within a Paediatric Emergency Department .
LTHT has developed a Sepsis Screening Tool (SST) which is designed to be used by relatively junior nursing staff to improve the likelihood of considering sepsis and therefore requesting a senior medical review. The SST is intended to be completed at admission or if there is a clinical deterioration, such as an increase in PAWS score to 10 or above.
The tool contains various checkbox items that if present suggest a high risk of sepsis. These include abnormal respiratory rate, mottling, rash or appearing blue, high heart rate, low blood pressure, altered conscious level and parental or health professional concern. High temperature needs to be 38 degrees C or more and then only in patients less than 4 months old so is less discriminatory.
There are secondary checkbox items indicating a moderate risk of sepsis including new leg pain, cold extremities, reduced urine output and temperature at any age greater than 39 degrees C.
A single positive score mandates urgent assessment by a senior decision maker defined as a doctor of ST4 grade or higher, or equivalent allied health professional and if sepsis is confirmed to ensure prompt management, including giving IV antibiotics within 60 minutes.
The SST tool is not designed to diagnose sepsis directly as this is the task of the senior decision maker but rather to prompt a targeted assessment, which will confirm sepsis or specifically eliminate it.
Acknowledging that the trust’s SST had not been deployed in any assessment of Edward that was undertaken in the LGI PED, a trust witness told the inquest that work was ongoing to ensure a consistent application of the SST as between the PED and the paediatric in-patient units at the Leeds Children’s Hospital.
As a coroner making a report of this nature, it is not for me to recommend to any third party that the Sepsis Screening Tool developed by the Leeds Teaching Hospitals Trust, or any document like it, should be either more widely disseminated to, or adopted as official guidance for, Paediatric Emergency Departments across England and Wales.
” Source location Edward Richard Jones · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to consistently deploy the Sepsis Screening Tool across Paediatric Emergency and paediatric in-patient settings
Wider context from the report “The inquest was told it is acknowledged nationally that there is no Sepsis Screening Tool which is validated for use in Paediatric Emergency Departments or has a sensitivity or specificity which makes it a useful tool for escalation within a Paediatric Emergency Department.
LTHT has developed a Sepsis Screening Tool (SST) which is designed to be used by relatively junior nursing staff to improve the likelihood of considering sepsis and therefore requesting a senior medical review. The SST is intended to be completed at admission or if there is a clinical deterioration, such as an increase in PAWS score to 10 or above.
The tool contains various checkbox items that if present suggest a high risk of sepsis. These include abnormal respiratory rate, mottling, rash or appearing blue, high heart rate, low blood pressure, altered conscious level and parental or health professional concern. High temperature needs to be 38 degrees C or more and then only in patients less than 4 months old so is less discriminatory.
There are secondary checkbox items indicating a moderate risk of sepsis including new leg pain, cold extremities, reduced urine output and temperature at any age greater than 39 degrees C.
A single positive score mandates urgent assessment by a senior decision maker defined as a doctor of ST4 grade or higher, or equivalent allied health professional and if sepsis is confirmed to ensure prompt management, including giving IV antibiotics within 60 minutes.
The SST tool is not designed to diagnose sepsis directly as this is the task of the senior decision maker but rather to prompt a targeted assessment, which will confirm sepsis or specifically eliminate it.
Acknowledging that the trust’s SST had not been deployed in any assessment of Edward that was undertaken in the LGI PED , a trust witness told the inquest that work was ongoing to ensure a consistent application of the SST as between the PED and the paediatric in-patient units at the Leeds Children’s Hospital .
As a coroner making a report of this nature, it is not for me to recommend to any third party that the Sepsis Screening Tool developed by the Leeds Teaching Hospitals Trust, or any document like it, should be either more widely disseminated to, or adopted as official guidance for, Paediatric Emergency Departments across England and Wales.
” Source location Edward Richard Jones · Prevention of Future Deaths 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 Update paediatric sepsis guidance in 2026 and consider replacing the traffic-light system with an NPEWS-based approach.
Verbatim wording from the response “We are planning to update our guidance on paediatric sepsis in 2026 and will consider adapting the current ‘traffic light’ system to one that is based on NPEWS.” Source location Response from National Institute for Health and Care Excellence
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation There are several sepsis screening or trigger tools available for use in paediatric emergency departments, contrary to the report’s premise.
Verbatim wording from the response “Contrary to your comment that nationally there is no sepsis screening tool validated for use in a paediatric emergency department, there are several screening tools that clinicians can use. These include our guidance NG254, the Sepsis Trust documents, the AoMRC documents, or local guides, such as the one from Leicester (see attached). These are, however, ‘sepsis trigger scores’ and rely on both an earlier more general severity of illness score (such as NPEWS, PAWS etc.) and a clinician observing the child and thinking ‘could this be sepsis’. Our guidance” Source location Response from National Institute for Health and Care Excellence
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Concerns raised 1
Delays in assessment, diagnosis, treatment and transfer of postoperative sepsis View source
This report raised 10 other concerns. They are not shown here because they do not form part of this recurring concern.
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AI-generated summary
Keith James Hankin · 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
Keith James Hankin was admitted for an elective optical urethrotomy on 8 September 2023, developed sepsis shortly after the procedure, was transferred to Worthing Hospital, and died there on 11 September 2023. The report identifies concerns about poor clinical governance and lack of integration, oversight and clinician assessment within the Community Urology Service, as well as multiple omissions in his pre-operative, intra-operative and post-operative care at Goring Hall Hospital, including delays in recognising and treating sepsis and transferring him for further management.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Delays in assessment, diagnosis, treatment and transfer of postoperative sepsis
Wider context from the report “6. Management of Mr Hankin at Goring Hall Hospital
There were multiple omissions in the pre-operative, intra-operative and post operative care provided by Goring Hall Hospital which individually and collectively contributed to Mr Hankin’s death. This included a failure to recognise Mr Hankin underlying medical co-morbidities rendered him unfit to have his operative procedure at the hospital. More specifically the post-operative assessment and support provided by the consultant anaesthetist and surgeon led to a delay in assessing and diagnosing sepsis and thereafter giving appropriate and timely antibiotics and facilitating an earlier transfer to the NHS Hospital for further management . This gives rise to a concern that there was a lack of understanding by the senior clinicians (in the absence of any local and national guidelines provided at the inquest) requiring them to remain responsible for the care of patients throughout their time in a private hospital rather than delegating the care to a Resident Medical Officer who is more likely than not to be insufficiently experienced in managing such critical situations.
” Source location Keith James Hankin · Prevention of Future Deaths report
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Implement a Care of the Deteriorating Patient policy defining consultant and Resident Medical Officer responsibilities and requiring escalation when consultants fail to respond appropriately.
Verbatim wording from the response “Consultants’ responsibilities are further reiterated within the comprehensive suite of clinical policies that are implemented across the CHG estate. Of particular relevance in this case is CHG’s Care of the Deteriorating Patient policy, which plainly sets out the expectations of both consultants and RMOs when managing patient deteriorations, and is incontrovertibly clear that consultants remain responsible for clinical care throughout a patient’s stay in a CHG hospital. Further, the policy mandates that a failure by a consultant to respond in line with their responsibilities must be escalated to the senior management team within the hospital.” Source location Response from Circle Health Group
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing policies sufficiently establish consultants’ continuing responsibility for patients and define RMO and consultant responsibilities during deterioration.
Verbatim wording from the response “I can confirm that GHH, as with all CHG sites, operates a consultant-led care model which is adopted across the private sector. Consultants’ responsibilities are clearly and robustly identified in CHG’s Practising Privileges policy, which draws upon the GMC’s Good Medical Practice and associated national guidance with which all doctors are expected to comply. CHG’s policy explicitly states: “The practitioner retains responsibility for patients they have treated during the patient’s entire clinical pathway in the relevant CHG hospital”.” Source location Response from Circle Health Group
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Failures by individual clinicians fall outside prosecutorial remit because prosecutorial powers extend only to registered providers or registered managers.
Verbatim wording from the response “CQC’s prosecutorial powers only extend to registered persons. A registered person means either the provider or their registered manager. Failures by individuals are not within our remit; therefore, we cannot pursue this matter any further.” Source location Response from Care Quality Commission
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18 Jun 2025 Charlotte Louise ALDERSON · Prevention of Future Deaths report Suffolk
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Concerns raised 1
Lack of expeditiously developed measures for early identification and treatment of sepsis View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
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Charlotte Louise ALDERSON · 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
Charlotte Louise Alderson became seriously unwell from 17 December 2022 and died on 21 December 2022 after a rapidly progressing beta haemolytic streptococcus infection led to septic shock and multi-organ failure. Concerns were raised about the differing outcomes produced by the CENTOR and FEVERPAIN scoring systems, the need for improved tools to identify sepsis or risk of sepsis early, and failures of the NHS Interoperability Toolkit handover between 111 and 999 services.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Lack of expeditiously developed measures for early identification and treatment of sepsis
Wider context from the report “b. Evidence received during the Inquest indicated that a number of existing measures within the National Health Service are capable of modification to provide testing tools for the early identification of sepsis/risk of sepsis and which would better inform decisions to prescribe antibiotics . These include CRP, finger prick and lateral flow tests. The risks associated with sepsis and the speed with which a rapid deterioration can occur in patients without clear warning signs of sepsis being present, are well known. There is therefore a need for the expeditious development of measures which assist clinicians in the early identification and treatment of sepsis.
” Source location Charlotte Louise ALDERSON · Prevention of Future Deaths report
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Fund and support research developing sepsis diagnostics, including point-of-care CRP-VLDL and finger-prick tests.
Verbatim wording from the response “Treatment of sepsis relies on keeping antibiotics working. Developing diagnostics that enable early detection of infections to drive optimal antimicrobial usage is a priority for this government, as set out in the 2024-29 UK antimicrobial resistance national action plan. The government is committed to driving evidence generation to improve our understanding of sepsis diagnosis and immediate management. DHSC continues to fund research through the NIHR and has provided over £21 million in programme funding for sepsis diagnostics and screening since 2020, over £14 million of which was focused on research into sepsis-related diagnostics.” Source location Response from Department of Health and Social Care
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11 Jun 2025 Lila Airelle Marsland · Prevention of Future Deaths report Manchester South
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Concerns raised 1
Failure to embed the Child Sepsis Screening Tool in assessment and treatment of children and young people View source
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response
Tameside and Glossop Integrated Care NHS Foundation Trust
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 4
Tameside and Glossop Integrated Care NHS Foundation Trust
Conduct daily PEWS and sepsis audits, share results in safety huddles, review themes weekly and provide targeted training.
View source
Tameside and Glossop Integrated Care NHS Foundation Trust
Use an electronic triage system with mandated sepsis screening questions that cannot be bypassed.
View source
Tameside and Glossop Integrated Care NHS Foundation Trust
Maintain annual triage audits and rolling training for practitioners using the Manchester Triage System.
View source
Tameside and Glossop Integrated Care NHS Foundation Trust
Deliver monthly sepsis simulations and recurring multidisciplinary simulation training for adult and paediatric emergency departments.
View source See 1 more action
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Lila Airelle Marsland · 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
Lila Marsland became unwell with headache, fever, lethargy and neck pain and was discharged from hospital with a diagnosis of viral tonsillitis. She was found to have died at home around six and a half hours after discharge; the inquest recorded that she died as a consequence of undiagnosed and untreated pneumococcal meningitis. Concerns included the embedding of the Child Sepsis Screening Tool, implementation of relevant NICE guidance, the adequacy and recording of clinical assessments, and fragmented storage and sharing of clinical information.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to embed the Child Sepsis Screening Tool in assessment and treatment of children and young people
Wider context from the report “1. Having carefully considered the oral evidence given in court by a range of different clinicians with varying roles and remits, I am concerned that, notwithstanding the work the Trust has undertaken in response to Lila’s death, the Child Sepsis Screening Tool is not yet fully embedded in the minds of those who assess and treat Children and Young People at the Trust ;
” Source location Lila Airelle Marsland · Prevention of Future Deaths 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 daily PEWS and sepsis audits, share results in safety huddles, review themes weekly and provide targeted training.
Verbatim wording from the response “The Trust have implemented regular audits for PEWS and sepsis. Since February 2025 this has converted to daily audits. The results of these audits are shared on safety huddles and immediate actions taken. The Paediatric ED Matron reviews the audits weekly, sends action emails if themes appear and if there is any individual learning identified there will be further training provided by the Paediatric ED Matron and the Practice Based Educators (PBE).” Source location Response from Tameside and Glossop Integrated Care NHS Foundation Trust
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Use an electronic triage system with mandated sepsis screening questions that cannot be bypassed.
Verbatim wording from the response “There has been a redesign to the electronic triage form so that you cannot bypass the sepsis screening questions. The ED Matron has worked closely with system developers to create an e-Card Triage System with mandated sepsis screening which forms part of the sepsis bundle. The Manchester Triage System (MTS) is in place. All triage practitioners are registered on the MTS system and annual triage audits of all triage practitioners are in place (this is on-going). Triage training is a rolling programme throughout the year, ensuring any triage practitioners who require further support or training have the opportunity to access the programme supported and delivered by the triage train the trainers and practice-based educators.” Source location Response from Tameside and Glossop Integrated Care NHS Foundation Trust
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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 Maintain annual triage audits and rolling training for practitioners using the Manchester Triage System.
Verbatim wording from the response “There has been a redesign to the electronic triage form so that you cannot bypass the sepsis screening questions. The ED Matron has worked closely with system developers to create an e-Card Triage System with mandated sepsis screening which forms part of the sepsis bundle. The Manchester Triage System (MTS) is in place. All triage practitioners are registered on the MTS system and annual triage audits of all triage practitioners are in place (this is on-going). Triage training is a rolling programme throughout the year, ensuring any triage practitioners who require further support or training have the opportunity to access the programme supported and delivered by the triage train the trainers and practice-based educators.” Source location Response from Tameside and Glossop Integrated Care NHS Foundation Trust
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Deliver monthly sepsis simulations and recurring multidisciplinary simulation training for adult and paediatric emergency departments.
Verbatim wording from the response “Sepsis simulations (SIM) are delivered monthly, the latest being in July 2025. Focus weeks have been held in April 2024 and September 2024 for both adults and paediatric ED, in addition to a sepsis focus week in March 2025. Throughout the week commencing 14th July 2025 there was an additional sepsis focus week aimed at all walk-in patients and there will be a further sepsis focus week commencing 15th September 2025 as it is World Sepsis Day on 13th September 2025.” Source location Response from Tameside and Glossop Integrated Care NHS Foundation Trust
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing sepsis training, audits and improvement work demonstrate that the screening tool is embedded among staff assessing and treating children and young people.
Verbatim wording from the response “I consider the above evidence demonstrates that the Trust is providing training for sepsis, identifying learning and implementing these changes effectively and validates that the Trust is ensuring that sepsis is embedded in the minds of those who assess and treat children and young people.” Source location Response from Tameside and Glossop Integrated Care NHS Foundation Trust
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9 Apr 2025 Bernard Lyon · Prevention of Future Deaths report Manchester South
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Concerns raised 1
Delays in providing antibiotics in accordance with sepsis needs during high emergency-department demand View source
This report raised 7 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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Bernard Lyon · 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
Bernard Lyon, who had dysphagia and was living at Hyde Nursing Home, developed sepsis and aspiration pneumonia and died at Tameside General Hospital on 30 January 2024. The report describes concerns about the nursing home's management capacity, staffing and adherence to his modified diet plan, as well as multi-agency oversight, communication with families, ambulance handover delays and delays in administering antibiotics in a very busy emergency department.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Delays in providing antibiotics in accordance with sepsis needs during high emergency-department demand
Wider context from the report “6. The Emergency Department at TGH was extremely busy on the day Mr Lyon arrived which was not unusual. The sheer volume of patients who were seriously ill meant that there was a delay in him being given antibiotics in accordance with his need . The Trust had taken steps to address this, but it was accepted that where there was a significant demand on an ED compliance with the national sepsis guidance was far more difficult to achieve .
” Source location Bernard Lyon · Prevention of Future Deaths report
Open source report
Concerns raised 2
Failure to trigger sepsis six and provide required antibiotics when indicated View source Absence of a digital alert for the need to implement sepsis six View source
Linked response
Royal Cornwall Hospitals NHS Trust
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 7
Royal Cornwall Hospitals NHS Trust
Share the patient’s story with AMU staff, focusing on neutropenic sepsis, hypothermia and the sepsis six bundle.
View source
Royal Cornwall Hospitals NHS Trust
Convene an AMU educational awayday focused on sepsis and the deteriorating patient.
View source
Royal Cornwall Hospitals NHS Trust
Increase compliance with sepsis training to 80% within four months and 90% within six months, excluding staff on leave.
View source
Royal Cornwall Hospitals NHS Trust
Maintain mandatory sepsis training for nurses and healthcare assistants as statutory and essential training.
View source
Royal Cornwall Hospitals NHS Trust
Provide sepsis update lunchtime training sessions for doctors.
View source
Royal Cornwall Hospitals NHS Trust
Apply the sepsis screening tool to all blood pressure machines.
View source
Royal Cornwall Hospitals NHS Trust
Develop a sepsis alert within the new e-Care system to digitally flag when the sepsis six should be actioned.
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Michael Ramon JERVIS · 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
Michael Ramon Jervis died at Royal Cornwall Hospital Truro on 16 July 2023 from neutropenic sepsis, a recognised complication of chemotherapy for testicular cancer. The report found a 20-hour delay in administering antibiotics after observations indicated they were required, and identified the absence of a digital alert that could have alerted staff to implement the Sepsis Six bundle.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to trigger sepsis six and provide required antibiotics when indicated
Wider context from the report “(1) Repeated observations and NEWS scores were taken by numerous staff members which indicated that sepsis six should be triggered and that antibiotics were required but this did not happen .
(2) There was an absence of a digital alert on hospital software, which could have alerted staff to the need to implement sepsis six.
” Source location Michael Ramon JERVIS · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Absence of a digital alert for the need to implement sepsis six
Wider context from the report “(1) Repeated observations and NEWS scores were taken by numerous staff members which indicated that sepsis six should be triggered and that antibiotics were required but this did not happen.
(2) There was an absence of a digital alert on hospital software , which could have alerted staff to the need to implement sepsis six .
” Source location Michael Ramon JERVIS · Prevention of Future Deaths 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 Share the patient’s story with AMU staff, focusing on neutropenic sepsis, hypothermia and the sepsis six bundle.
Verbatim wording from the response “b. The patient’s story will be shared with AMU staff (following consent), emphasising patient impact, to enhance staff awareness and understanding. The aim is to have this completed within the next six months and this will specifically focus upon neutropenic sepsis, hypothermia and the sepsis six bundle.” Source location Response from Royal Cornwall Hospital Trust
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Convene an AMU educational awayday focused on sepsis and the deteriorating patient.
Verbatim wording from the response “c. An educational awayday is being arranged for AMU staff, with a focus on sepsis and the deteriorating patient. This will be convened within the next six months.” Source location Response from Royal Cornwall Hospital Trust
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Increase compliance with sepsis training to 80% within four months and 90% within six months, excluding staff on leave.
Verbatim wording from the response “The Trust has undertaken the following action since the death of Mr Jervis; In the Acute Medical Unit (AMU) the matron has formulated an action plan to promote learning within the ward and wider care-group. This plan includes improving and monitoring compliance with mandatory sepsis training.” Source location Response from Royal Cornwall Hospital Trust
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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 Maintain mandatory sepsis training for nurses and healthcare assistants as statutory and essential training.
Verbatim wording from the response “Sepsis training for healthcare assistants and nurses became mandated in August 2024 and is now part of the Trust’s statutory and essential training. In addition, lunchtime training sessions have been arranged for our doctors with regards to sepsis and this has been implemented.” Source location Response from Royal Cornwall Hospital Trust
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 Provide sepsis update lunchtime training sessions for doctors.
Verbatim wording from the response “Sepsis training for healthcare assistants and nurses became mandated in August 2024 and is now part of the Trust’s statutory and essential training. In addition, lunchtime training sessions have been arranged for our doctors with regards to sepsis and this has been implemented.” Source location Response from Royal Cornwall Hospital Trust
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 Apply the sepsis screening tool to all blood pressure machines.
Verbatim wording from the response “To continue to raise awareness and increase visibility, the Trust’s sepsis lead is applying the sepsis screening tool to all blood pressure machines.” Source location Response from Royal Cornwall Hospital Trust
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 Develop a sepsis alert within the new e-Care system to digitally flag when the sepsis six should be actioned.
Verbatim wording from the response “Unfortunately, NerveCentre (a national system) does not allow for this. However, RCHT is implementing a new e-Care digital electronic patient record (EPR) system and the sepsis lead nurse will be involved in the implementation to develop a sepsis alert/trigger to digitally ‘flag’ when the ‘sepsis six’ needs to be actioned.” Source location Response from Royal Cornwall Hospital Trust
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 current NerveCentre system cannot support a digital sepsis alert, although an alert is planned for the replacement EPR system.
Verbatim wording from the response “There was an absence of a digital alert on hospital software, which could have alerted staff for the need to implement sepsis six:” Source location Response from Royal Cornwall Hospital Trust
Open published response
12 Jul 2024 Sandra Phillpott · Prevention of Future Deaths report Blackpool and the Fylde
View report summary
Concerns raised 2
Delays in providing urgent treatment for suspected sepsis View source Failure to recognize suspected sepsis View source
Linked response
Blackpool Teaching Hospitals NHS Foundation Trust
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 7
Blackpool Teaching Hospitals NHS Foundation Trust
Deliver sepsis briefings, safety-huddle and team-meeting teaching, mandated recognition-and-action training, induction training and ward-level knowledge audits.
View source
Blackpool Teaching Hospitals NHS Foundation Trust
Implement an updated sepsis policy and clinical sepsis proforma aligned with national guidance and the sepsis six.
View source
Blackpool Teaching Hospitals NHS Foundation Trust
Increase validated sepsis pathway auditing to 40 patients weekly and use identified learning themes to target improvement.
View source
Blackpool Teaching Hospitals NHS Foundation Trust
Operate a trust-wide sepsis quality-improvement collaborative and disseminate its change package through clinical teams.
View source
Blackpool Teaching Hospitals NHS Foundation Trust
Hold weekly Emergency Department sepsis review meetings to examine data and drive improvement.
View source
Blackpool Teaching Hospitals NHS Foundation Trust
Focus the next 12 months of quality-improvement work on escalation pathways through expert forums and trust-wide events.
View source
Blackpool Teaching Hospitals NHS Foundation Trust
Submit incidents for delayed sepsis identification, conduct rapid reviews where harm is suspected, and feed identified learning into the sepsis pathway group.
View source See 4 more actions
×
AI-generated summary
Sandra Phillpott · 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
Sandra Phillpott died on 31 October 2023 after developing sepsis and multi-organ failure following E. coli O157 and pneumococcal infections. The report identifies delays in recognising suspected sepsis and providing antibiotics and intravenous fluids, with attention initially focused on ruling out pulmonary embolism and deep vein thrombosis.
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.
PFD Monitor interpretation Delays in providing urgent treatment for suspected sepsis
Wider context from the report “• The concern relates to the recognition of suspected sepsis, and the need for timely provision of treatment for suspected sepsis .
• Notwithstanding that I determined that from the available evidence timely treatment would not have altered the fatal outcome, I remain firmly of the view this report is necessary.
• I was informed at the inquest that there have been significant improvements in the management of sepsis within the Emergency Department.
• This court has raised concerns with the hospital Trust about this issue previously, and I know it is an issue which the Trust is very aware of and I do not doubt that efforts have been made to make improvements, but having conducted this inquest into Sandra’s death, in my view there remains a risk that sepsis will go unrecognized, and urgent treatment will be delayed , putting patients attending Blackpool Victoria Hospital at risk. My duty to write this report is therefore met. It is not for me to be prescriptive about what action ought to be taken, but to raise this concern should I feel this is necessary.
” Source location Sandra Phillpott · Prevention of Future Deaths 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.
PFD Monitor interpretation Failure to recognize suspected sepsis
Wider context from the report “• The concern relates to the recognition of suspected sepsis , and the need for timely provision of treatment for suspected sepsis.
• Notwithstanding that I determined that from the available evidence timely treatment would not have altered the fatal outcome, I remain firmly of the view this report is necessary.
• I was informed at the inquest that there have been significant improvements in the management of sepsis within the Emergency Department.
• This court has raised concerns with the hospital Trust about this issue previously, and I know it is an issue which the Trust is very aware of and I do not doubt that efforts have been made to make improvements, but having conducted this inquest into Sandra’s death, in my view there remains a risk that sepsis will go unrecognized , and urgent treatment will be delayed, putting patients attending Blackpool Victoria Hospital at risk. My duty to write this report is therefore met. It is not for me to be prescriptive about what action ought to be taken, but to raise this concern should I feel this is necessary.
” Source location Sandra Phillpott · Prevention of Future Deaths 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 Deliver sepsis briefings, safety-huddle and team-meeting teaching, mandated recognition-and-action training, induction training and ward-level knowledge audits.
Verbatim wording from the response “To support staff knowledge, briefings for all staff were developed and shared through safety huddles, team meetings and training. This was supported by ward/ unit level ‘teach/learn’ audits whereby the ward managers/leaders ask staff questions related to sepsis each month and use the results to improve practice. For sustainability sepsis was included in the mandated recognition and act training for all clinical staff and inductions.” Source location Response from Blackpool Teaching Hospitals
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 Implement an updated sepsis policy and clinical sepsis proforma aligned with national guidance and the sepsis six.
Verbatim wording from the response “A new sepsis proforma was developed for clinical practice and the policy updated. Historically, the Trust had contributed to the AQUA audit for peer review and had a composite process score of around 30% and ranked below 12th position in the league tables within our area. The AQUA audit is of a small percentage of patients each quarter. This process was improved by increasing the number of audits to 40 patients per week, through the clinical audit team, with validated data. The Associate Directors. This more detailed audit provided the team with richer data which enabled the identification of learning themes and areas of targeted focus. The learning themes were used to design a quality improvement collaborative which began in May 22 for the management of patients with sepsis.” Source location Response from Blackpool Teaching Hospitals
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 Increase validated sepsis pathway auditing to 40 patients weekly and use identified learning themes to target improvement.
Verbatim wording from the response “A new sepsis proforma was developed for clinical practice and the policy updated. Historically, the Trust had contributed to the AQUA audit for peer review and had a composite process score of around 30% and ranked below 12th position in the league tables within our area. The AQUA audit is of a small percentage of patients each quarter. This process was improved by increasing the number of audits to 40 patients per week, through the clinical audit team, with validated data. The Associate Directors. This more detailed audit provided the team with richer data which enabled the identification of learning themes and areas of targeted focus. The learning themes were used to design a quality improvement collaborative which began in May 22 for the management of patients with sepsis.” Source location Response from Blackpool Teaching Hospitals
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 Operate a trust-wide sepsis quality-improvement collaborative and disseminate its change package through clinical teams.
Verbatim wording from the response “A new sepsis proforma was developed for clinical practice and the policy updated. Historically, the Trust had contributed to the AQUA audit for peer review and had a composite process score of around 30% and ranked below 12th position in the league tables within our area. The AQUA audit is of a small percentage of patients each quarter. This process was improved by increasing the number of audits to 40 patients per week, through the clinical audit team, with validated data. The Associate Directors. This more detailed audit provided the team with richer data which enabled the identification of learning themes and areas of targeted focus. The learning themes were used to design a quality improvement collaborative which began in May 22 for the management of patients with sepsis.” Source location Response from Blackpool Teaching Hospitals
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 Hold weekly Emergency Department sepsis review meetings to examine data and drive improvement.
Verbatim wording from the response “For areas with high numbers of sepsis patients, such as the Emergency Department (ED), a weekly review meeting was put in place and has continued to ensure focus on data and improvements. Overall compliance to the actions from the organisation are reviewed through a monthly subject matter expert group for sepsis, where the data, training, new ways of working are monitored.” Source location Response from Blackpool Teaching Hospitals
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 Focus the next 12 months of quality-improvement work on escalation pathways through expert forums and trust-wide events.
Verbatim wording from the response “The Trust continues to keep sepsis in focus with monthly updates provided to the Trust’s Clinical Governance Committee, and Quality Assurance Committee regarding sepsis pathway compliance. The current area of focus for improvement are:” Source location Response from Blackpool Teaching Hospitals
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 Submit incidents for delayed sepsis identification, conduct rapid reviews where harm is suspected, and feed identified learning into the sepsis pathway group.
Verbatim wording from the response “I would like to assure you that if our records show that a patient’s sepsis has not been identified within the appropriate timescale, incidents are submitted on the Trust’s incident management system. Where harm is suspected the Trust undertakes a Rapid Review which is presented to the twice weekly Rapid Review Panel. This process ensures that appropriate learning is identified and a proportionate learning response deployed. Where learning is identified, this is fed into the Trust’s sepsis pathway group to enable further improvements to be initiated.” Source location Response from Blackpool Teaching Hospitals
Open published response
4 Jul 2024 David John Morris · Prevention of Future Deaths report East London
View report summary
Concerns raised 2
Failure to treat and escalate suspected sepsis promptly View source Failure to identify the extent of gastrostomy leaks and onset of sepsis View source
This report raised 7 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked responses
Barking, Havering and Redbridge University Hospitals NHS Trust Department of Health and Social Care Medicines and Healthcare products Regulatory Agency
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 5
Barking, Havering and Redbridge University Hospitals NHS Trust
Provide a dedicated 24-hour, seven-day Critical Care Outreach Team service.
View source
Barking, Havering and Redbridge University Hospitals NHS Trust
Design and implement Martha’s Rule, enabling patients, relatives and staff to request rapid Critical Care Outreach Team review.
View source
Barking, Havering and Redbridge University Hospitals NHS Trust
Include deteriorating-patient processes and policy in mandatory Basic Life Support training for clinical staff.
View source
Barking, Havering and Redbridge University Hospitals NHS Trust
Develop online training for recognising deteriorating patients.
View source
Barking, Havering and Redbridge University Hospitals NHS Trust
Operate a weekly deteriorating patient panel to review deterioration and use learning to change practice.
View source See 2 more actions
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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.
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 .
” Source location David John Morris · Prevention of Future Deaths 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.
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.
” Source location David John Morris · Prevention of Future Deaths report
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 Provide a dedicated 24-hour, seven-day Critical Care Outreach Team service.
Verbatim wording from the response “The Trust has implemented an increase in our Critical Care Outreach Team (CCOT) model since April 2024. Previously this service was offered between the hours of 8am to 8pm with no dedicated service outside of these hours. Since April 2024 this is now a dedicated twenty-four-hour service delivered seven days a week to ensure continuity and access to specialised teams as required.” Source location 2024-0360 - Response from Barking Havering and Redbridge NHS Trust
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 Design and implement Martha’s Rule, enabling patients, relatives and staff to request rapid Critical Care Outreach Team review.
Verbatim wording from the response “Additionally, the Trust is currently in the process of designing and implementing Martha’s Rule, which is based upon the case of Martha Mills who died in 2021 after developing sepsis in hospital. In response to hers and other cases related to the management of deterioration, the Secretary of State for Health and Social Care and NHS England committed to implementing ‘Martha’s Rule’; to ensure the vitally important concerns of the patient and those who know the patient best are listened to and acted upon.” Source location 2024-0360 - Response from Barking Havering and Redbridge NHS Trust
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 Include deteriorating-patient processes and policy in mandatory Basic Life Support training for clinical staff.
Verbatim wording from the response “Finally, there is now a deteriorating patient panel group which meets weekly and reviews patients that have had a deterioration in clinical condition and uses this information/learning to change practice both locally and Trust-wide. To assist in the familiarity of the process and policy for deteriorating patients, this is now included in Basic Life Support training which is an essential requirement for all clinical staff. There is also a development of an online training for the recognition of deteriorating patients.” Source location 2024-0360 - Response from Barking Havering and Redbridge NHS Trust
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 online training for recognising deteriorating patients.
Verbatim wording from the response “Finally, there is now a deteriorating patient panel group which meets weekly and reviews patients that have had a deterioration in clinical condition and uses this information/learning to change practice both locally and Trust-wide. To assist in the familiarity of the process and policy for deteriorating patients, this is now included in Basic Life Support training which is an essential requirement for all clinical staff. There is also a development of an online training for the recognition of deteriorating patients.” Source location 2024-0360 - Response from Barking Havering and Redbridge NHS Trust
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 Operate a weekly deteriorating patient panel to review deterioration and use learning to change practice.
Verbatim wording from the response “Finally, there is now a deteriorating patient panel group which meets weekly and reviews patients that have had a deterioration in clinical condition and uses this information/learning to change practice both locally and Trust-wide. To assist in the familiarity of the process and policy for deteriorating patients, this is now included in Basic Life Support training which is an essential requirement for all clinical staff. There is also a development of an online training for the recognition of deteriorating patients.” Source location 2024-0360 - Response from Barking Havering and Redbridge NHS Trust
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
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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 Trust will respond separately to the concerns about care and processes.
Verbatim wording from the response “I understand that the Barking, Havering & Redbridge University Trust will also be responding separately to your concerns and that the London region of NHS England is” Source location 2024-0360 - Response from DHSC
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 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 The MHRA is best placed to address concerns about the gastrostomy device and its product information.
Verbatim wording from the response “The Chief Safety Officer at the MHRA is also providing a response to your report. And I have received assurances that they have carefully considered your concerns raised. I will not duplicate their response concerning the gastrostomy device mentioned in your report, as they are best placed to answer your concerns. As per the request from MHRA, you may wish to share the brand name and manufacturer of the gastrostomy device used on Mr Morris and MHRA will be able to check the wording in their specific product information to ensure the appropriate advice on checking for leaks is present.” Source location 2024-0360 - Response from DHSC
Open published response
Actions and positions describe what organisations say in published responses. Implementation is not independently verified.