Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0620, written 11 Dec 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 11 Dec 2025 |
|---|---|
| Reference | 2025-0620 |
| Deceased | Ashana Charles |
| Coroner | Andrew Harris |
| Coroner area | South London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Lewisham and Greenwich NHS Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Coroner for South London Area South London Coroner's Office 2nd Floor, Davis House Robert Street, Croydon, CR0 1QQ Tel Email: REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. 2. 3. , Chief National Medical Examiner, National Medical Examiner’s Office, 6 Alie Street, London E1 8QT , Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), 10 South Colonnade, Canary Wharf, London E14 4PU , Interim National Director of Patient Safety, NHSE (National Patient Safety Committee), NHS England, Wellington House, 133-155 Waterloo Road, London SE1 8UG 1 CORONER I am Andrew Harris, assistant coroner for the coroner area of South London 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST An investigation was opened on 28th November 2018 into the death of Mrs Ashana Charles on 20th November 2018 in Queen Elizabeth Hospital, Woolwich. The inquest was part heard in London Inner South by me as senior coroner on 13th February 2020. Following alarming evidence first heard in court, the pathologist recommended investigations and expert evidence that required international searching, which was not completed before I fell ill and retired from London Inner South. In December 2024 the case was transferred to South London. The resumed inquest concluded on 9th December 2025. The conclusion of the inquest was that she died from acute obstruction of small pulmonary arteries by cellulose fibres, which had embolised from inadvertently contaminated intravenous infusions at some stage of product preparation or administration. The source of fibres could not be identified, but the sudden death from embolism would have been prevented had a 1.2 micron filter been used in IV infusion, which was not standard practice at the time. 4 CIRCUMSTANCES OF THE DEATH Mrs Charles was admitted to hospital in September 2018 with weight loss and anaemia from severe immunosuppressed advanced stage AIDS. She improved on retroviral therapy and treatment of complications, including CMV colitis, but she had persistent diarrhoea and hypalbuminaemia requiring parenteral feeding. A Hickman line was inserted on 14/11, Ganciclovir was begun and IV antibiotics continued. At 22.30 on 19/11 IV feeding was begun with Nutriflex Omega Special, to which vitamins had been added by the manufacturer. The standard giving set normally used on the ward would have had an integrated 15-micron filter. There was no record of deviation from routine aseptic technique in administration. On the morning of 20/11, she was clinically improved on review; a hot feeling was sensed when medication was infused, but she had no temperature. At 13.55 her unexpected cardiac arrest was witnessed and CPR begun immediately. She was declared dead at 14.36. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: 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 associated with IV feeding were probably underreported due to inadequate investigation. gave an opinion that deaths that might be 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 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 BBraun 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. 6 ACTION SHOULD BE TAKEN Concern1: The Chief Medical Examiner’s attention is drawn to the opinion that medical examiners should be advised of the need to retain IV feed equipment for pathological investigation where there is an unexplained death within 24 hours of parenteral feeding. Concern 2: The MHRA and NHSE (National Patient Safety Service) are asked to consider whether the regulatory systems for production and administration of parenteral feeding need to be better integrated, with sharing of risk assessment data and consistent guidance. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 6th February 2026. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise, you must explain why no action is proposed. Your response should be sent to: Clerk, at 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested (mother), Lewisham & Greenwich Persons: NHS Trust, BBraun Medical Ltd, and to the British Pharmaceutical Nutrition Group, who I believe may find it useful or of interest, and may also send them a copy of your response. (husband), I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any other person who I believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response. 9 11th December 2025 Assistant Coroner Professor Andrew Harris
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Andrew Harris
Assistant Coroner, South London
South London Coroner’s Service
2nd Floor Davis House
Robert Street
Croydon
CR0 1QQ
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
26th January 2026
Dear Coroner,
Re: Regulation 28 Report to Prevent Future Deaths – Ashana Charles who died
on 20th November 2018.
Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 11th
December 2025 concerning the death of Ashana Charles on 20th November 2018. In
advance of responding to the specific concerns raised in your Report, I would like to
express my deep condolences to Ashana’s family and loved ones. NHS England is
keen to assure the family and yourself that the concerns raised about Ashana’s care
have been listened to and reflected upon.
Your Report raises concerns with the inconsistent guidance on the use of filters in
parenteral (PN) feeding. You highlighted that the regulatory systems for the production
and administration of PN feeding need to be better integrated, with sharing of risk
assessment data and consistent guidance.
The British Pharmaceutical Nutrition Group (BPNG) issued a position statement in
August 2025 recommending that all PN admixtures should be administered via a filter
with a pore size of 1.2 μm. This position statement includes:
“The National Institute for Health and Care Excellence (NICE) guidelines for PN for
adults and neonates provide no guidance on the use of filters for PN administration.
The Royal College of Nursing (RCN) in their Standards for infusion therapy, which are
currently under review, state that for lipid infusions or total nutrient preparations that
require filtration, a 1.2 μm filter should be used. The UK Injectable Medicines Guide
(Medusa) in their PN monographs advise the use of 1.2 μm filters, and in their
paediatric guide, 1.2μm filters for lipid-containing bags and syringes and 0.2μm filters
for aqueous (lipid-free) admixtures. To our knowledge there is currently no other UK-
based national guidance on filtering PN admixtures….
… The guidance in the 2001 BPNG position statement remains valid and our guidance
is unchanged. Detailed advice on filtering PN needs to be included in national UK PN
guidance such as that proposed by NICE, BAPEN or similar. For clarity, we also
suggest manufacturers of PN and PN amino acid/lipid emulsions revise their SPCs to
include appropriate advice on filtering, including details on recommended filter pore
size for the administration of their products.”
This information suggests that there are potential gaps in:
1. current national resources regarding the recommendation to use a filter when
administering parenteral nutrition;
2. the Marketing Authorisation Holders Summaries of Product Characteristics
(SmPC) information regarding the requirement to use appropriate filters.
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.
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.
Local Action
The NHS England London Region Team have liaised with the South East London
Integrated Care System (ICS) on the action taken by Lewisham & Greenwich NHS
Trust in relation to this case. They have informed us that the Trust has evaluated the
use of 1.2 micron filters in PN feeding and is in the process of setting up the ordering
process for the 1.2-micron inline filters. This will ensure the correct products are
ordered and that there is central stock control by the pharmacy service. Once this has
been completed, training will commence for relevant staff. This action is being
monitored through the relevant committees within the Trust.
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.
Thank you for bringing these important patient safety issues to my attention and please
do not hesitate to contact me should you need any further information.
Yours sincerely,
National Medical Director
NHS England
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