Prevention of Future Deaths reports · 2014
Regulation 28 report to prevent future deaths, reference 2014-0491, written 12 Nov 2014. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 12 Nov 2014 |
|---|---|
| Reference | 2014-0491 |
| Deceased | Patricia Mellor |
| Coroner | Jane Gillespie |
| Coroner area | Nottinghamshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | University Hospitals of Derby and Burton NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | none published |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. Derby Hospitals NHS Foundation Trust
2. Medicines and Healthcare Product Regulatory Agency
3. National Patient Safety Agency
4. NICE
5. Patricia Mellor’s family
6. Chief Coroner
1
CORONER
I am, Jane Gillespie, Assistant Coroner, for the coroner area of Nottinghamshire.
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
On 29th January 2014 I commenced an investigation into the death of Patricia Ann
Mellor, aged 63. The investigation concluded at the end of the inquest on 7th October
2014. The conclusion of the inquest was:
On the 24th day of January 2014 Patricia Ann Mellor died as a result of aspiration
pneumonia. This was a direct result of the hypoxic brain injury that she suffered
following a cardiac arrest during surgery in 2004. The cardiac arrest during general
anaesthesia was a consequence of a phenomenon known as acquired Long QT
Syndrome, due to a combination of citalopram, nortriptyline and ranitidine therapies.
This reaction could not have been predicted in 2004.
4
CIRCUMSTANCES OF THE DEATH
On 30.03.04 Mrs Mellor underwent an arthroscopic examination of her left
temporomandibular joint for chronic pain in this area. Mrs Mellor was subject to a
thorough assessment by
her surgery.
necessary for the operation given Mrs Mellor’s difficulty in opening her jaw and her
significant reflux disease. She had also previously experienced severe post-anaesthetic
nausea and vomiting and episodes of hypertension during general anaesthetic.
had some concerns regarding the placement of a breathing pipe
Consultant Anaesthetist, on the morning of
was confident that these risks could be managed and the general anaesthetic
went ahead, in preparation for the operation which was to be performed by
Consultant Maxillofacial Surgeon. Very shortly into the operation, before any
incision was made, Mrs Mellor became hypertensive, did not respond to the usual
medications and went into cardiac arrest. Resuscitation was commenced and continued
for 20 minutes before spontaneous circulation was re-established. When Mrs Mellor’s
was taken off sedation she was found to have a hypoxic brain injury. Since that time she
has been severely disabled and fully dependent on others for her care and health
needs. On 24th January 2014 she died as a result of aspiration pneumonia, 10 years
after suffering her hypoxic brain injury.
Following this event, a full investigation was carried out to try to establish the cause of
her cardiac arrest. Anaphylactic shock, abnormal heart valve/s and abnormalities in the
heart muscle were all excluded. It was concluded that Mrs Mellor had acquired Long QT
Syndrome, from the combination of citalopram, nortriptyline and ranitidine therapies. It
was considered that this caused a reaction to general anaesthesia, which in turn
provoked the Long QT Syndrome, leading to cardiac arrest.
Long QT syndrome (LQTS) is a disorder of the heart's electrical activity. The term "long
QT" refers to an abnormal pattern seen on an electrocardiogram. It can cause sudden,
uncontrollable, dangerous arrhythmias. This may be an inherited naturally occurring
condition or it may be acquired. Acquired LQTS can be caused by certain
medication/combinations of certain medications.
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. –
Consultant Anaesthetist has advised that in response to this incident,
the Derby Hospitals NHS Trust undertook the following action;
· All 12 lead ECG devices were programmed to print a “Long QTc” warning
when detected
· An educational programme on LQTS was delivered to all Anaesthetists
working in the Trust
· A protocol was developed to require a pre-operative ECG for all patients
taking drugs listed on the expert database at “high” and “intermediate” risk
levels of causing cardiac arrest – this overrides the advice in the NICE CG3
document
· When a prolonged QTc is discovered;
o The patient is questioned about cardiac arrest or sudden
unexpected death in a young family member; if this is discovered,
the patient is referred to a cardiologist to exclude Congenital LQTS
o The patient has plasma electrolyte levels (specifically potassium,
magnesium and calcium) measured irrespective of any contrary
advice in the NICE CG3 guideline. Any abnormal low level is treated
before surgery
· The Anaesthetist for the relevant operating list is alerted to any abnormal
QTc finding
· A protocol was developed to; (1) guide the safe administration of general
anaesthesia to patients with LQTS, and (2) guide the optimum management
of cardiac arrest if this occurs under anaesthesia
· Investment was provided for electronic pumps to allow the ready availability
of TIVA
further advised that the likelihood of this event being due to a
drug-related phenomenon was reported to the Medicines and Healthcare
Products Regulatory Agency (MHRA) using the “yellow card” scheme.
There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a
warning on the potential risks of cardiac arrest when administered to
patients with LQTS
· The product information for other drugs such as 5HT3 anti-emetics should
contain a warning on the potential risks of cardiac arrest when administered
to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be
highlighted in the regular bulletins from the Agency
Furthermore,
reported that recommendations be sent to NICE
updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative
assessment before following the recommendation not to perform a 12 lead
ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-
operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTC to be specifically
examined in all patients receiving agents deemed to be of “high” and
“intermediate” risk of inducing cardiac arrest in LQTS
that despite
recommendations, no action has been taken by these agencies.
the above notifications and
advised
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.
I require you to provide an explanation and reasons regarding;
the decision taken not to respond to the recommendations set out above
(i)
(ii) whether this decision will be reviewed in light of this report
(iii) if no action is to be taken in light of this report, the reasons for this
(iv) if action is to be taken, what that action will be and the timescales for such
7
YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this report,
namely by 7th January 2015 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 Derby Hospitals NHS Foundation Trust, Medicines
and Healthcare Product Regulatory Agency, National Patient Safety Agency, NICE and
Patricia Mellor’s family
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
Date 12th November 2014 Jane Gillespie, Assistant Coroner
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