PFD report

Mrs Ashana Charles · Prevention of Future Deaths report

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Issued 11 Dec 2025•South 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.

View original report
Concerns
8

Raised in this report

Recipients
2

Named on the report

Responses found
1

Of 2 recipients

Stated actions
1

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 raised8

  1. Lack of assurance that PN and filter manufacturers issue consistent guidance and operationally consistent products
  2. Failure to establish adequate safety assurance from visual checks of PN products
  3. Failure of drug manufacturer guidance to specify the need, desirability or context of filter use for Omega Special
Responses linked to these concerns

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

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    The MHRA is the appropriate authority to regulate medical devices and medicines and coordinate relevant filtering guidance with other bodies.

    Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking 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

Lack of assurance that PN and filter manufacturers issue consistent guidance and operationally consistent products

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

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 to establish adequate safety assurance from visual checks of PN products

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

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 drug manufacturer guidance to specify the need, desirability or context of filter use for Omega Special

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

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 to submit 1.2 micron filter use for governance oversight

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

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 to retain infusion equipment and supplies for forensic investigation

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

Is this part of a recurring concern?

Yes — Failure to preserve clinical evidence and data after serious clinical events; Failure to retain safety-critical source records and evidence; Unreliable specialist and forensic support for death investigations.

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

Inconsistency between regional guidance on use of filters in parenteral feeding

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

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

Inadequate investigation of deaths potentially associated with IV feeding

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

Is this part of a recurring concern?

Yes — Inadequate safety incident investigations.

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 use 1.2 micron filters as standard practice in parenteral feeding

Wider context from the report

“1. That no source of contamination could be identified due to the infusion set, filter, feeding bag and lines not being retained for forensic investigation. The pathologist Professor ████████ gave an opinion that deaths that might be associated with IV feeding were probably underreported due to inadequate investigation. 2. ████████, expert pharmacist and pharmaceutical regulator drew attention to a) The inconsistency at the time between US and European and UK guidance about use of filters in parenteral feeding (PN). b) Reference to filters for Omega Special by the drug manufacturer at the time indicating an appropriate filter “if one was used”, but not its need or desirability or context of use, and the value of manufacturers and health providers integrating their approach to risk management. c) The use of the 1.2 micron filter at the time was not standard practice, perhaps because of cost or operational reasons as the filter often led to blockages and delays in IV feeding. Now both that BNPG guidance and B Braun recommend the use of 1.2 micron filters on Omega Special label, but that does not give assurance that all PN and filter manufacturers issue the same guidance nor that their products are operationally consistent with guidance. d) Lewisham & Greenwich NHS Trust have begun to re-evaluate the use of 1.2 micron filters in PN feeding but the matter had not yet gone to its governance department but should do so next year. There was a need for those responsible for decision implementation in hospitals nationally to cross work with manufacturers and specialist bodies. e) Uncertainty whether the reported visual checks of PN products by batch rather than individually provided adequate safety assurance. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this respondent position was interpreted

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

PFD Monitor interpretation

The MHRA is the appropriate authority to regulate medical devices and medicines and coordinate relevant filtering guidance with other bodies.

Verbatim wording from the response

“We note that your Report is also addressed to the Medicines and Healthcare Products Regulatory Agency (MHRA) and are of the opinion that, given the recommendations within the BPNG position statement and your concerns, the MHRA, as the regulator of medical devices and medication, is the appropriate responsible authority to respond to the question of regulation. It is within their remit to ensure that relevant information is included in the designated SmPCs. The MHRA is also expertly placed to liaise with NICE, the British Association for Parenteral and Enteral Nutrition (BAPEN) and the RCN for incorporation of the recommendations they consider necessary into relevant guidance around administration of parenteral nutrition.”

Source location

Response from NHS England
Page 2 · response
Published 18 December 2025

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.1

  1. 1

    Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group and share resulting learning across national and regional NHS services.

    Stated by NHS EnglandStated completedThe respondent said that this action was complete when they made their response on 18 December 2025.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    Increased demand for 1.2 μm filters is not considered a supply risk because the devices have other intravenous administration uses.

    Stated by NHS EnglandDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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

Discuss Prevention of Future Deaths reports through the Regulation 28 Working Group and share resulting learning across national and regional NHS services.

Verbatim wording from the response

“I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Ashana, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.”

Source location

Response from NHS England
Page 2 · response
Published 18 December 2025

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

Increased demand for 1.2 μm filters is not considered a supply risk because the devices have other intravenous administration uses.

Verbatim wording from the response

“We have taken the opportunity to consider whether to anticipate any availability issues, should there be an increased demand for 1.2 μm filters across healthcare upon greater awareness of recommended practice. However, given these devices have other uses within intravenous administration, we do not consider this to be a risk.”

Source location

Response from NHS England
Page 2 · response
Published 18 December 2025

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

Official responses located
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Data last updated 7 September 2026