Prevention of Future Deaths reports · 2014

John Adams

Regulation 28 report to prevent future deaths, reference 2014-0293, written 1 Jul 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report1 Jul 2014
Reference2014-0293
DeceasedJohn Adams
CoronerVeronica Hamilton-Deeley
Coroner areaBrighton & Hove
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses publishednone published

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

THE CORONER’S OFFICE
WOODVALE, LEWES ROAD
BRIGHTON

BN2 3QB

Telephone: Brighton
Fax: Brighton

VERONICA HAMILTON-DEELEY, LL.B.
Her Majesty’s Senior Coroner
for the City of Brighton & Hove

Assistant Coroners

CATHARINE PALMER LL.B (HONS)
MICHAEL KEEN

KAREN HENDERSON, BSC,BM,MRCPI,FRCA
GILVA D.J.TISSHAW, BA(LAW)HONS

CORONERS SOCIETY OF ENGLAND AND WALES

ANNEX A

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)

NOTE: This form is to be used after an inquest.

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:

1. Matthew Kershaw Chief Executive, Brighton & Sussex University Hospitals, Royal
Sussex County Hospital, Eastern Road, Brighton.

2. National Patient Safety Agency, 4-8 Maple Street, London

3. National Research Ethics Service, National Patient Safety Agency, 4-8 Maple Street,
London.

1 CORONER

| am Veronica HAMILTON-DEELEY, Senior Coroner, for the City of Brighton and Hove

2 CORONER’S LEGAL POWERS

Lmake 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

On 13" February 2014 | commenced an investigation into the death of John Henry ADAMS. The
investigation concluded at the end of the inquest on 11" June 2014. The conclusion of the inquest
was a narrative conclusion:- John Henry ADAMS died as a result of multipie complications of
appropriate cardiac intervention in circumstances where, just prior to the procedure, he was recruited
to a cardiac trial.

4 CIRCUMSTANG F THE DEATH
My concerns really relate to the Trial to which he was recruited on the day of the PCI, the 30"
January 2014.

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.

VERONICA HAMILTON-DEELEY, LL.B.
Her Majesty’s Senior Coroner
for the City of Brighton & Hove

THE CORONER’S OFFICE
WOODVALE, LEWES ROAD
BRIGHTON

Ney <¥ 5 y

Ye W) BN2 30B
AVES Qe

Assistant Coroners (Ss (GY: Telephone: Brighton

CATHARINE PALMER LL.B (HONS) SACU ET EON Fax: Brighton

MICHAEL KEEN

KAREN HENDERSON, BSC,BM,MRCPI,FRCA

GILVA D.J.TISSHAW, BA(LAW)HONS

The MATTERS OF CONCERN are as follows. —
THE CARDIAC TRIAL

(1) It seems that the Trial was in very early stages at the Brighton Hospital and that Mr. Adams may
have been the fourth patient to have been recruited.

(2) Was it appropriate that he should have been recruited within an hour or so prior to his procedure
commencing?

(3) Did this give him time to read the several page booklet which was provided to him and to absorb
the information and give informed consent?

(4) Is it appropriate for a visiting Cardiologist, only present at the Hospital for a few hours every
fortnight to be the "operator" to take part in this trial?

(5) Given that the Consultant Cardiologist in Mr. Adams' case does only visit Brighton once a
fortnight for a few hours, and this was his first patient on the Trial, was he himself appropriately
informed?

In evidence | was told that he was already late for a Clinic when he left the Hospital, believing
that Mr. Adams was fine, and that involvement in the trial meant that the procedure took longer
than normal - possibly about half an hour longer.

Does that sort of pressure result in the best outcome?

(6) The Hospital notes for Mr. Adams admission on the 30" do not mention the view (apparently
formed within an hour or so of surgery), that it was the pacing wires; which was the extra
requirement of the Trial; which caused the cardiac tamponade.

Why not? Why was this information effectively concealed?

(7) The hospital notes in Brighton, the letter of referral to Kings College Hospital and the report to
the Coroner all give the impression, because of the wording used, that what had happened at
the PCI was that the diagonal artery had dissected and this is what is believed to have caused
the pericardial effusion and tamponade.

The Consultant Cardiologist is the only person to have used the expression "dissection" to
describe the damage to the diagonal artery which occurred during the PCI.

Should more care be taken on terminology? In this case it seems to have lead to a great deal of
confusion.

(8) One of the organisers of the Trial has written in Mr. Adams' notes that he has been notified of
what has happened to Mr. Adams but he makes no mention of what is believed to have occurred
as a result of the Trial. Why not?

Why was the Trial not mentioned to Kings College Hospital in the Referral letter dated the des
February 2014?

(9) Finally; surely the death of a patient while on a Trial is a matter of major concern to the Trial
itself and yet no-one contacted the Coroner, either the original Coroner in South London or me,
Coroner for Brighton and Hove when | took over jurisdiction pursuant to Section 2 of the
Coroner’s and Justice Act, to let us know that this man had been on a Trial.

If | had known that, and in particular if | had been able to tell [INEM of that fact, she
would have been able to ascertain precisely where the bleeding/haemorrhage originated and
there would have been good clear helpful information for those managing the Trial and of course
future patients who might have benefited from it.

6 ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you AND your
organisation have the power to take such action.

VERONICA HAMILTON-DEELEY, LL.B. THE CORONER’S OFFICE
Her Majesty’s Senior Coroner WOODVALE, LEWES ROAD
for the City of Brighton & Hove BRIGHTON

BN2 3QB

Assistant Coroners

CATHARINE PALMER LL.B (HONS)
MICHAEL KEEN

KAREN HENDERSON, BSC,BM,MRCPI,FRCA
GILVA D.J.TISSHAW, BA(LAW)HONS

Telephone: Brighton
Fax: Brighton

rd YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report, namely by
26" August 2014. 1, Veronica Hamilton-Deeley, the senior 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

| have sent a copy of my report to the Chief Coroner and to the following Interested Persons

|

He Viedico-legal Manager, Brighton & Sussex University Hospitals,
Secretary of State for Health, Department of Health

Sir David Nicholson/Simon Stevens — Chief Executive NHS England

Chief Executive, National Patient Safety Agency, NHS Commissioning Board Authority,
4-8 Maple Street, London.

Cee

| have also sent it to:-

if amram Director for Clinical Quality and Primary Care, Lanchester House,
ratalgar Place, Brighton
2 a Director of Public Health, Lanchester House, Trafalgr Place, Brighton

Who may find it useful or of interest.
| 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 compiete 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.

Senior Coroner Brighton and Hove

73 St ot : \ 7,
9 Date: 1 July 2014 SIGNED BY: */ vee

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