Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0107, written 13 Apr 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 13 Apr 2021 |
|---|---|
| Reference | 2021-0107 |
| Deceased | Gary Day |
| Coroner | Edwin Buckett |
| Coroner area | Inner North London |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
Regulation 28: Prevention of Future Deaths report
Gary Day (died 16.12.2020)
THIS REPORT IS BEING SENT TO:
Medical Director
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
1
CORONER
I am: Edwin Buckett
Assistant Coroner
Inner North London
Poplar Coroner’s Court
127 Poplar High Street
London E14 0AE
2
CORONER’S LEGAL POWERS
I make this report under the Coroners and Justice Act 2009,
paragraph 7, Schedule 5, and
The Coroners (Investigations) Regulations 2013,
regulations 28 and 29.
3
INVESTIGATION and INQUEST
On the 24th December, 2020 Senior Coroner Hassell began an
investigation into the death of Gary Day who died aged 57, on the 16th
December, 2020 at the Royal London Hospital, Whitechapel Road,
London, E1.
The investigation concluded at the end of the inquest on 12th April, 2021
conducted by myself, Assistant Coroner Edwin Buckett.
I made a determination at inquest that the deceased died as a result of
air embolism which was caused by an elective endoresection operation
and/or associated operative treatment carried out at Moorfields Eye
Hospital on the 15th December, 2020.
4
CIRCUMSTANCES OF THE DEATH
1
Gary Day has a choroidal melanoma of the left eye. After discussing his
treatment options with clinicians at Moorfields Eye Hospital, he elected
to have that melanoma removed by an endoresection procedure at the
hospital.
On the 15th December, 2020 the operation, which took around 3 hours,
was completed at about 4pm. Pressurised air was not used in the
operation. Heavy oil was used as a means of attaching the retina.
Thereafter, Mr Day left the hospital at around 7.15pm, walking to a
waiting taxi which took him home.
Later that evening, he became unwell. Between 9-10pm, he was taken
by ambulance to the Royal London Hospital and admitted to the critical
care unit.
Whilst in hospital a CT pulmonary angiogram was reviewed by a
Consultant Radiologist which was suggestive of a large volume of air
embolus.
Mr Day became severely unwell and died at about 10.50am on the 16th
December, 2020, some 19 hours after the operation.
The post mortem examination of Mr Day concluded that his death was
caused by air embolus which in turn had been caused by the
endoresection operation.
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.
Evidence was given by medical staff at Moorfields Eye Hospital that:
1. Mr Day was not informed that there was any risk of death from the
surgery he elected to have, even though there is a risk of air
embolus, and therefore death, from this procedure. The Consent
Form he signed did not make any reference to a risk of death;
2. There was no check carried out for air embolus after the
operation;
3. There was confusion between medical staff as to whether or not
Mr Day was to be kept in for an over-night stay in hospital. As it
turned out, he was not advised to stay in hospital over-night and
2
was allowed to leave 3 hours after the operation had concluded.
This meant that when he was taken to the Royal London Hospital
on the evening of the 15th December, 2020 clinical staff in hospital
did not have immediate access to any medical notes concerning
his earlier procedure.
I am concerned that:
(a) Any patient who elects to have an endoresection operation of an
choroidal melanoma faces a risk (however small) of air embolism
and therefore death. This must be made clear to all patients
undergoing such a procedure;
(b) There ought to be some check/investigation post operation to
determine (or to try and determine as best possible) whether air
may have entered the blood stream during the operative
procedure;
(c) Patients undergoing this operation (which normally lasts between
2-3 hours) should be advised to stay in hospital as an in-patient
for at least 24 hours, which would enable careful and extended
monitoring of their condition and a swift and informed transfer, if
necessary, to an acute care unit of a hospital in the event of a
deterioration in their condition.
6
ACTION SHOULD BE TAKEN
In my opinion, action should be taken to prevent future deaths and I
believe that you and/or your organisation 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 June 2021. 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 following.
3
HHJ Thomas Teague QC, the Chief Coroner of England & Wales
, on behalf of the family of Gary Day
I am 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
DATE 13.4.2021 SIGNED BY ASSISTANT
CORONER
Edwin Buckett
4
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.
Edwin Buckett Assistant Coroner Inner North London Poplar Coroner’s Court 127 Poplar High Street London E14 0AE 11 June 2021 Dear Mr Buckett Regulation 28 Prevention of Future Deaths (PFD) report: Gary Day (died 16 December 2020) I am writing in response to the PFD report that you issued on 13 April 2021, following your investigation into the death of Mr Gary Day from an air embolism. This followed a surgical procedure (endoresection of a choroidal melanoma) undertaken on 15 December 2020 at Moorfields Eye Hospital. We have completed our internal investigation and have shared the report with next of kin, and her family. Our investigation identified a number of opportunities for improvement and shared learning; implementation of the agreed actions will be closely monitored via our internal governance processes. We have also shared our completed investigation report with the Care Quality Commission and our lead commissioner and commissioning support unit. Our internal investigation considered potential air sources as possible, or likely sources of air entry, based on precautions taken and/or the volume of air present. However, it was not possible to conclude exactly how air was able to enter the patient’s circulatory system. It is confirmed, because of the existence of the recording of the procedure, that air did not enter the patient’s circulation visibly via the eye, as this would have been observed as a significant volume of air bubbles. However, only occasional small singular bubbles were seen either during surgery, or on subsequent review of a recording of the procedure. There are four explanations for the subsequent development of air embolus that have not been excluded or considered in detail as a possibility during the course of this investigation. Further consideration of these possibilities is warranted, but this will be done as part of a larger piece of research that considers the worldwide prevalence of similar cases. The four possible causes of air embolus have been identified as: Heavy liquid; Heavy liquid interaction with another substance (e.g. silicone oil); Patient physical or medical conditions that makes a patient more or less disposed to the risk of air embolus; and A previously unrecognised source. Following careful consideration of your concerns, in light of our investigation findings and consideration of information shared by endoresection surgeons from around the world, our responses are set out below: Concern (a) Any patient who elects to have an endoresection operation of a choroidal melanoma faces a risk (however small) of air embolism and therefore death. This must be made clear to all patients undergoing such a procedure. Trust response As we have been unable to establish the cause of the air embolus, the trust has elected to not undertake further procedures of this nature. We acknowledge your concern and if this procedure is performed at any time in the future we will ensure that patients are informed of the associated risk of death. Concern (b) There ought to be some check/investigation post operation to determine (or to try and determine as best possible) whether air may have entered the blood stream during the operative procedure. Trust response The trust does not have the facilities to undertake the enhanced level of monitoring that patients undergoing this procedure would require. As we have been unable to establish the cause of the air embolus, the trust has elected to not undertake further procedures of this nature. We acknowledge your concern and if this procedure is performed at any time in the future we will ensure that it is undertaken in a facility that can provide the post-operative monitoring and intensive care support required. Concern (c) Patients undergoing this operation (which normally lasts between 2-3 hours) should be advised to stay in hospital as an in-patient for at least 24 hours, which would enable careful and extended monitoring of their condition and a swift and informed transfer, if necessary, to an acute care unit of a hospital in the event of a deterioration in their condition. Trust response As described above, the trust does not have the facilities to undertake the enhanced level of monitoring that patient’s undergoing this procedure would require. As we have been unable to establish the cause of the air embolus, the trust has elected to not undertake further procedures of this nature. We acknowledge your concern and if this procedure is performed at any time in the future we will ensure that it is undertaken in a facility that can provide the post- operative monitoring and intensive care support required. I hope this response is satisfactory and we would be happy to answer any further queries. Yours sincerely, Consultant vitreoretinal surgeon Medical director
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