PFD report

David John Morris · Prevention of Future Deaths report

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Issued 4 Jul 2024•East London

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
9

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
21

Described in responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised9

  1. Poor communication in cancer diagnosis and treatment
  2. Failure of serious incident investigations to identify relevant reviewing clinicians
    Part of recurring concern: Inadequate safety incident investigationsPart of recurring concern: Unreliable formal safety-incident management processes
  3. Failure to treat and escalate suspected sepsis promptly
    Part of recurring concern: Failure to reliably recognise and respond promptly to sepsis
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.19

  1. Action

    Continue working with NHS England and local systems to reduce cancer waiting times and support earlier-stage diagnosis.

    Stated by Department of Health and Social CareStated in progressThe respondent said that this action was in progress when they made their response on 4 July 2024.
  2. Action

    Require Learning Review Group sign-off with Board Executive attendance for quoracy when approving patient safety investigations.

    Stated by Barking, Havering and Redbridge University Hospitals NHS TrustStated completedThe respondent said that this action was complete when they made their response on 4 July 2024.
  3. Action

    Develop online training for recognising deteriorating patients.

    Stated by Barking, Havering and Redbridge University Hospitals NHS TrustStated in progressThe respondent said that this action was in progress when they made their response on 4 July 2024.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.5

  1. Position

    The specific device instructions cannot be reviewed without the gastrostomy device’s brand and manufacturer.

    Stated by Medicines and Healthcare products Regulatory AgencyUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Poor communication in cancer diagnosis and treatment

Wider context from the report

“1. Mr Morris’s diagnosis and treatment for cancer was delayed due to poor organisation and communication at the Trust. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure of serious incident investigations to identify relevant reviewing clinicians

Wider context from the report

“4. The initial serious investigation report into Mr Morris’s death was unfit for purpose. The report to investigate or even identify the Registrar who reviewed Mr Morris on the evening of 3rd May 2022. Since then, no effective review has been undertaken by the Trust upon how this deficient report gained executive approval. ”

Is this part of a recurring concern?

Yes — Inadequate safety incident investigations; Unreliable formal safety-incident management processes.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to treat and escalate suspected sepsis promptly

Wider context from the report

“2. During the evening of 3rd May 2022 going into the early hours of 4th May 2022, Doctors and nurses failed to identify the extent of Mr Morris’s gastrostomy leak and the onset of sepsis. After identifying symptoms of sepsis, staff failed to treat and escalate Mr Morris’s case resulting in a delay of three and a half hours before a medical review commenced emergency treatment. ”

Is this part of a recurring concern?

Yes — Failure to reliably recognise and respond promptly to sepsis.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Poor organisation of cancer diagnosis and treatment

Wider context from the report

“1. Mr Morris’s diagnosis and treatment for cancer was delayed due to poor organisation and communication at the Trust. ”

Is this part of a recurring concern?

Yes — Unreliable coordination of cancer diagnosis and 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. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Ineffective controlled drug management systems for detecting prolonged theft and self-administration

Wider context from the report

“5. The Trust did not have effective controlled drug management systems in place to detect a prolonged and persistent course of conduct from an employed nurse who was stealing and self- administering controlled drugs in the workplace. ”

Is this part of a recurring concern?

Yes — Inadequate safeguards for access to dangerous drugs.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to effectively review how deficient investigation reports gain executive approval

Wider context from the report

“4. The initial serious investigation report into Mr Morris’s death was unfit for purpose. The report to investigate or even identify the Registrar who reviewed Mr Morris on the evening of 3rd May 2022. Since then, no effective review has been undertaken by the Trust upon how this deficient report gained executive approval. ”

Is this part of a recurring concern?

Yes — Unreliable senior oversight of safety incident reviews.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Poor or absent clinical records

Wider context from the report

“3. During Mr Morris’s ward-based treatment on 3 & 4th May 2022 clinical records were either of a poor standard or were non-existent. The absence of clear records impeded the effective investigation of this death by the Trust’s governance teams and the Coroner. ”

Is this part of a recurring concern?

Yes — Incomplete, inaccurate or unavailable clinical and care records.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to identify the extent of gastrostomy leaks and onset of sepsis

Wider context from the report

“2. During the evening of 3rd May 2022 going into the early hours of 4th May 2022, Doctors and nurses failed to identify the extent of Mr Morris’s gastrostomy leak and the onset of sepsis. After identifying symptoms of sepsis, staff failed to treat and escalate Mr Morris’s case resulting in a delay of three and a half hours before a medical review commenced emergency treatment. ”

Is this part of a recurring concern?

Yes — Failure to reliably recognise and respond promptly to sepsis.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Unfit serious incident investigation reports

Wider context from the report

“4. The initial serious investigation report into Mr Morris’s death was unfit for purpose. The report to investigate or even identify the Registrar who reviewed Mr Morris on the evening of 3rd May 2022. Since then, no effective review has been undertaken by the Trust upon how this deficient report gained executive approval. ”

Is this part of a recurring concern?

Yes — Inadequate safety incident investigations; Unreliable formal safety-incident management processes.

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

Continue working with NHS England and local systems to reduce cancer waiting times and support earlier-stage diagnosis.

Verbatim wording from the response

“I wholeheartedly agree with you regarding the importance of organisations across the health system working together to ensure effective cancer diagnosis, and I regret that this did not occur in Mr Morris’ case. It is important to ensure that the issues you outlined in your report are not repeated. Thus, we will continue to work alongside NHSE and local systems to reduce waiting times and deliver on the NHS Long-Term Plan ambitions to diagnose 75% of cancers at stage 1 and 2 by 2028.”

Source location

2024-0360 - Response from DHSC
Page 2 · response
Published 4 July 2024

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

Require Learning Review Group sign-off with Board Executive attendance for quoracy when approving patient safety investigations.

Verbatim wording from the response

“On completion of Patient Safety Incident Investigations (PSIIs) there is a Learning Review Group (LRG) which reviews the contents of the reports to ensure adequate exploration of key issues has occurred and that the family has had an opportunity to input into the investigation; and ensures the improvement action plan both aligns with learning identified and is sufficiently robust to counteract the existing safety issues identified. The Terms of Reference for this meeting have been updated and now include a Board Executive (or nominated deputy) who must be in attendance for quoracy when signing off investigations.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 3 · response
Published 4 July 2024

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
Page 2 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Explore installing CCTV in medicine preparation rooms.

Verbatim wording from the response

“In light of the concerns raised by the learned Coroner, the Trust is trialing a digital key system on each ward, together with exploring installing CCTV into the Medicine Preparation rooms. An initial discussion with suppliers took place in July 2024.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 3 · response
Published 4 July 2024

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
Page 2 · response
Published 4 July 2024

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

Introduce a Medicine Management Nurse role to support compliance with medication policies.

Verbatim wording from the response

“To assist with compliance with the medication policies, a Medicine Management Nurse is being introduced within the Trust and the recruitment process is currently underway. Advertising of the post should begin in October 2024 with appointment following this.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 3 · response
Published 4 July 2024

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

Trial a digital key system on each ward for controlled medication management.

Verbatim wording from the response

“In light of the concerns raised by the learned Coroner, the Trust is trialing a digital key system on each ward, together with exploring installing CCTV into the Medicine Preparation rooms. An initial discussion with suppliers took place in July 2024.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 3 · response
Published 4 July 2024

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 Incident Oversight Learning Group to review concerning incidents and commission further learning responses where needed.

Verbatim wording from the response

“There is a weekly Incident Oversight Learning Group (IOLG) whereby all incidents that are considered of concern are discussed with specific terms of reference. This includes background information and a review of the entire pathway which a patient has encountered when systems issues are identified; thereby including any omissions that may have occurred with the previous Serious Incident Framework. The Incident Oversight Learning Group meetings are chaired by either the Medical Director for Patient Safety and Patient Experience or the Director of Nursing for Quality and Safety, and this group decides when to commission a further PSIRF learning response.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 3 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Use the Patient Safety Investigation Response Framework with multidisciplinary investigations and centrally allocated investigating officers.

Verbatim wording from the response

“Since October 2023 there has been a change in the process of investigating significant patient safety incidents at BHRUT. This has now been changed to the Patient Safety Investigation Response Framework (PSIRF) which uses multidisciplinary investigations and reviews with multiple responsible authors. In line with NHS England guidance, the Investigating Officer is centrally allocated by the Quality and Safety team and, whenever possible, these are allocated outside of the Clinical Group where the incident occurred.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 3 · response
Published 4 July 2024

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

Require responsible consultant approval before removing or deferring any cancer patient from the Patient Tracker List.

Verbatim wording from the response

“Mr Morris’s treatment plan and diagnosis was delayed and complicated in part due to being downgraded in severity on the Patient Tracker List which led to a breakdown in communication between clinical pathways. With immediate effect, no patients that are currently on a Patient Tracker List for any cancer diagnosis can be removed or deferred without approval of the responsible consultant. This is to ensure that administrative processes have a clear oversight of a senior clinician who takes full responsibility for the treatment plan.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 1 · response
Published 4 July 2024

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

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
Page 1 · response
Published 4 July 2024

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

Restructure cancer administration pathways to provide new clinical oversight and streamlined communication.

Verbatim wording from the response

“In addition, a restructure of the cancer administration pathways is underway by the Speciality Manager for cancer performance; under the oversight of the Chief Operating Officer. This restructure is proposed to finish by 30 September 2024, with its implementation expected to result in new clinical oversight and streamlined communication.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 1 · response
Published 4 July 2024

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

Make contemporaneous, clear clinical documentation a mandatory part of medical and nursing induction for new starters.

Verbatim wording from the response

“The standard of documentation was highlighted as being of a poor quality. The Trust is in the process of preparing for the introduction of an Electronic Patient Records (EPR) system, which is due to be adopted in May 2025. Adopting the EPR system will involve a process where contemporaneous and clear clinical documentation is made during clinical episodes of care; and this practice will be highlighted as a mandatory part of the medical and nursing induction process for all new starters.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 2 · response
Published 4 July 2024

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

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
Page 2 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Review the feasibility of CRABEL audits and prepare a plan for approval to assess medical record-keeping quality.

Verbatim wording from the response

“In addition, the Trust lead for mortality is reviewing the possibility of performing CRABEL audits (an audit tool designed by CRawford – BEresford – LAfferty) as a tool for the assessment of the quality of medical record keeping, with the ability to standardise audit and improvement across areas. A plan is due to be presented for approval in November 2024 following the second meeting of the Health Records Group.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 2 · response
Published 4 July 2024

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
Page 2 · response
Published 4 July 2024

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

Prepare for adoption of an Electronic Patient Records system supporting contemporaneous, clear clinical documentation.

Verbatim wording from the response

“The standard of documentation was highlighted as being of a poor quality. The Trust is in the process of preparing for the introduction of an Electronic Patient Records (EPR) system, which is due to be adopted in May 2025. Adopting the EPR system will involve a process where contemporaneous and clear clinical documentation is made during clinical episodes of care; and this practice will be highlighted as a mandatory part of the medical and nursing induction process for all new starters.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 2 · response
Published 4 July 2024

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

Assign sole responsibility and ownership for Controlled Medication Keys to identified individuals at the start of each shift.

Verbatim wording from the response

“A change in the process of Controlled Medication Keys is already in place since the incident, with individuals identified at the start of each shift with sole responsibility and ownership of these.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 3 · response
Published 4 July 2024

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 Quarterly Health Records Group to present and review best practice and learning opportunities.

Verbatim wording from the response

“In August 2024, the Medical Directorate has established a Quarterly Health Records Group where both best practice and learning opportunities will be presented and reviewed with action plans as appropriate.”

Source location

2024-0360 - Response from Barking Havering and Redbridge NHS Trust
Page 2 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The 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
Page 1 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The 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
Page 2 · response
Published 4 July 2024

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

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
Page 1 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The 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
Page 1 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The 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
Page 2 · response
Published 4 July 2024

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. 1

    Investigate the reported gastrostomy balloon-device risk by contacting manufacturers, assessing reports, and closing the investigation.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 4 July 2024.
  2. 2

    Monitor trends in infection incidence and deaths from sepsis with NHS England and the UK Health Security Agency.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 4 July 2024.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.2

  1. 1

    London region NHS England is engaging directly with the Trust about the concerns raised.

    Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
  2. 2

    The CQC will determine whether further action, monitoring or a regulatory response is required.

    Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Investigate the reported gastrostomy balloon-device risk by contacting manufacturers, assessing reports, and closing the investigation.

Verbatim wording from the response

“It is important to note that the MHRA did receive a safety report in December 2022 from NHS England from the National Reporting and Learning System (NRLS) regarding a fatality with a gastrostomy balloon device. Whilst the NRLS report did not include all the same details as this Regulation 28 report, the MHRA are confident that this is regarding the same patient due to the timeline of events. The NRLS report focussed on the possibility of human error and confusion between the enteral feeding port and the balloon port. The MHRA contacted all manufacturers for balloon gastrostomy devices who confirmed that they had received no similar reports and that they were implementing ENFit standards for their devices with the last of the non-ENFit products being available in June 2023.”

Source location

2024-0360 - Response from MHRA
Page 2 · response
Published 4 July 2024

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

Monitor trends in infection incidence and deaths from sepsis with NHS England and the UK Health Security Agency.

Verbatim wording from the response

“With the aim of improving our understanding of sepsis and its impacts, the Department works with NHSE and the UK Health Security Agency to monitor trends in infection incidence and deaths from sepsis, which are often complex and multifactorial issues. The National Institute for Health and Care Research (NIHR) also funds several studies into sepsis. In 2022, NIHR awarded £3.2m funding to the Sepsis Trials in Critical Care study (SepTIC), which will look to answer critical questions on sepsis diagnostics and treatment. It is our hope that continuing to improve our understanding of sepsis and how it can be better managed will improve outcomes for patients and reduce preventable deaths occurring in the future.”

Source location

2024-0360 - Response from DHSC
Page 3 · response
Published 4 July 2024

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

London region NHS England is engaging directly with the Trust about the concerns raised.

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
Page 1 · response
Published 4 July 2024

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The CQC will determine whether further action, monitoring or a regulatory response is required.

Verbatim wording from the response

“The CQC has confirmed that they are reviewing this case, and will consider what further action should be taken, and whether any monitoring of the trust, or regulatory response, is required.”

Source location

2024-0360 - Response from DHSC
Page 2 · response
Published 4 July 2024

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

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Data last updated 7 September 2026