Prevention of Future Deaths reports · 2018
Regulation 28 report to prevent future deaths, reference 2018-0050, written 10 Feb 2018. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 10 Feb 2018 |
|---|---|
| Reference | 2018-0050 |
| Deceased | Margaret Clark |
| Coroner | Simon Jones |
| Coroner area | Lancashire & Blackburn with Darwen |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Blackpool Teaching Hospitals NHS Foundation 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.
for Lancashire & Blackburn with Darwen
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO: M H R A
1
CORONER
I am Simon Jones Assistant Coroner , for Lancashire & Blackburn with Darwen
CORONER’S LEGAL POWERS
2
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.
http://www.legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7
http://www.legislation.gov.uk/uksi/2013/1629/part/7/made
3
INVESTIGATION and INQUEST
On 6th November 2017 I commenced an investigation into the death of Margaret Elizabeth Clark
aged 75. The investigation concluded at the end of the inquest on 6th February 2018. The
conclusion of the inquest was that Margaret Elizabeth Clark died from a rare but recognised
complication of surgery.
4
CIRCUMSTANCES OF THE DEATH
Margaret Elizabeth Clark suffered an oesophageal tear in the course of a transoesophageal
echocardiogram [“TOE”] carried out at Blackpool Victoria Hospital on the 9th May 2017. She was
transferred to Royal Preston Hospital, where the tear was repaired, but she died of sepsis which
developed as a result of the tear, on the 12th August 2017.
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 will occur unless action is taken. In the circumstances it
is my statutory duty to report to you.
The MATTERS OF CONCERN are as follows. –
I was told that in 2017 the types of probes used for TOEs were changed, to a design which
required covering with a sheath. Using that sheath, three fatal oesophageal tears had occurred
in the space of 5 months, involving in each case experienced anaesthetists who had conducted
TOEs routinely for many years without event. [I was told that there had been one previous
incident in the preceding 16 years]. The sheaths used – Ecolab Ultracover for TEE – were
replaced at Blackpool Victoria Hospital with alternative [softer] sheaths – Probetection TOE/TEE
Transducer Kit. Since the replacement sheaths have been used, there have been no incidents of
tear. I was told that the Ecolab sheaths may still be used in other hospitals and Trusts. A
Serious Incident Investigation Report expressed a concern that the tears may have resulted from
the use of the Ecolab sheaths, which [it was felt] created more resistance on insertion than had
been the case before their use.
(1) I believe you should review the use of the Ecolab sheaths and consider whether they should
not be replaced in all hospitals and Trusts by the Probetection sheaths.
Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, Lancashire, PR2 9NB
Tel 01772 536536 | Fax 01772 530752
6
ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you have the power
to take such action.
7
YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report, namely by
12th April 2018. 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.
8
COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following Interested Persons
Valerie Clark [daughter of the deceased] and Blackpool Teaching Hospitals NHS Foundation
Trust. I have also sent it to Alan Wilson [Senior Coroner for Blackpool] who may find it useful or
of interest.
I am also under a duty to send the Chief Coroner a copy of your response.
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 by the Chief Coroner.
9
Dated 10/02/2018
Signature
for Lancashire & Blackburn with Darwen
Coroner's Court, 2 Faraday Court, Faraday Drive, Fulwood, Preston, Lancashire, PR2 9NB
Tel 01772 536536 | Fax 01772 530752
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.
a Medicines & Healthcare products : MHRA Regulating Medicines and Medical Devices. Regulatory Agency MHRA 151 Buckingham Palace Road London Simon Jones SW1W 982 Assistant Coroner United Kingdom Coroner's Court, www.gov.uk/mhra 2 Faraday Court, Faraday Drive, Fulwood, Preston, Lancashire, PR2 9NB 11 April 2018 Dear Mr Jones REGULATION 28 REPORT TO PREVENT FUTURE DEATHS Thank you for contacting me and drawing our attention to the circumstances of the death of Margaret Elizabeth Clark in your Regulation 28 report to prevent future deaths. You wished to bring this matter to our attention in order that a review into the safety and reliability of Ecolab sheaths be undertaken with the hope that fatal consequences may be avoided as the MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. The MHRA requested and received from the manufacturer details of complaints recorded for this device. Ecolab sheaths were first placed on the market in 2010. Since then there have been over 425,000 devices sold throughout the EU. Ecolab reported that they had received only 8 complaints; none of which were serious. The MHRA are aware that not all incidents are reported. The MHRA performed a review of the adverse incident database, looking for incidents relating to Ecolab sheaths and found only two reports that relate to TOE probe covers splitting, this includes the report from Blackpool Victoria Hospital. The MHRA requested details of the ultrasound systems used in the reported incidents, but the Trust have not provided this information. The MHRA are unable to compare “softness” of sheaths on the market and therefore cannot recommend that Ecolab sheaths are replaced in all hospitals and Trusts by the Probetection sheaths. The safety of TOE probe covers will continue to be monitored and appropriate regulatory action to protect public health will be taken as and when necessary. | hope that you find this response satisfactory. Thank you for bringing your concerns to my attention. Yours sincerely Director of Devices Teleph E-mail:
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