Prevention of Future Deaths reports · 2016

Amelia Calvo

Regulation 28 report to prevent future deaths, reference 2016-0192, written 11 Mar 2016. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report11 Mar 2016
Reference2016-0192
DeceasedAmelia Calvo
CoronerFiona Borrill
Coroner areaManchester City
CategoryChild Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

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.

REGULATION 28: REPORT TO PREVENT FUTURE DEATHS

This report is made under paragraph 7, Schedule 5, of the Coroners and
Justice Act 2009 and regulations 28 and 29 of the Coroners
(Investigations) Regulations 2013.

Recipients
This report is being set to:

e Department of Health

Coroner

| am Fiona Borrill, HM Area Coroner for the area of Manchester City.

Coroner's legal powers

| 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.

Investigation and Inquest

On 31 March 2014 | commenced an investigation into the death of Amelia Celestine
Calvo, aged 1 day. The investigation concluded at the end of the inquest on 11
March 2016.

The cause of death was found to be:
ja Multi organ failure. Disseminated intravascular coagulation
1b Hypovolemic shock
1c Haemorrhage during procedure
2 Trisomy 18

The recorded a Narrative Conclusion: Natura! causes contributed to by a
minimisation of the risk of loss of intubation by not guarding the endotracheal tube in
a ventilated baby and a breakdown in communication between medical staff in
theatre on 28 March 2014.

Circumstances of death

The deceased was born at 31 weeks gestation on 27th March 2014 at 20:23 at St
Mary's Hospital as a twin delivery weighing 1.15kg. She was subsequently
diagnosed with Edwards Syndrome, a life limiting condition. She had poor respiratory
effort and was successfully intubated at the fourth attempt at 12 minutes of age. She
was transferred to the neonatal intensive care unit and remained ventilated. Cardiac
anomalies were diagnosed by ultra sound scan. Chest x-ray revealed that the
nasogastric tube looped in a blind ending oesophagus and a diagnosis of
oesophageal atresia with tracheo-oesophageal fistula was confirmed. To be treated
for this required urgent surgery to ligate the tracheo-oesophageal fistula, and this
procedure was listed for the afternoon of 28th March 2014. The deceased was safely
transferred to theatre at the Royal Manchester Children's Hospital at 13:45 on 28th
March 2014. In theatre and following a team briefing, at which the Paediatric
Surgeon was absent, the Paediatric Anaesthetist, following arrival of the Paediatric
Surgeon, performed a laryngoscopy which confirmed a grade 4 airway and this was
communicated to the theatre team, The evidence leads me to find that thereafter
there was a breakdown in communication between medical staff, as the Paediatric
Surgeon decided to proceed to examine the larynx himself and the Paediatric
Anaesthetist understood that there would be a further discussion as to whether to
proceed with a rigid bronchoscopy or alternatively a flexible bronchoscopy and seek
further specialist advice prior to surgery being undertaken. Despite the fact that the
endotracheal tube was not guarded by an anaesthetist or the deceased prepared for
a laryngoscopy, the Paediatric Surgeon inserted a bronchoscope and laryngoscope
into the deceased's mouth to view the back of the throat, the endotracheal tube
became dislodged and the deceased subsequently developed severe problems with
a difficult airway, pneumothoraces and bleeding. Despite all resuscitative measures
and interventions, she deteriorated and died at 18:01 on 28th March 2014.

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.

1. During the course of the inquest, | heard evidence from Po
Consultant Neonatologist, the independent expert instructed by the court that
the grading system used by anaesthetists to assess a patient's throat prior to
carrying out a laryngoscopy and assessment generally, namely the view being
classified as follows:

Grade |: Complete glottis visible

Grade II: Anterior glottis not seen

Grade III: Epiglottis seen, but not glottis

Grade IV: Epiglottis not seen

is not a classification that is generally used in neonatal practice.

oo;°0

°

advised that in fact this classification was ‘rarely’ used in neonatal
practice and that there were discussions currently being undertaken as to
creating a joint anaesthetic/neonatal guideline.

In Amelia’s case, the issue as to whether or not there was a
‘difficult/dangerous’ airway was not handed over by the neonatologists to the
paediatric anaesthetist prior to the surgery on 28 March 2014 as the
neonatologists did not consider 4 attempts at intubation at birth to be
indicative of a difficult airway.

HE aciditionally stated that in his Trust discussions were taking place in
the neonatology department with regard to using this classification system,
but there is no national guideline to this effect.

Action should be taken

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

1. | require to be advised as to whether the Department of Health is

considering, along with the appropriate Royal Colleges, the introduction of a
guideline to ensure clarity of assessment of the airway.

Your response

You are under a duty to respond to this report within 56 days of the date of this
report, namely by 15 July 2016. |, 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.

Copies and publication

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

| 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.

Ruan

F Borrill Date
H.M. Area Coroner — Manchester City area

Responses

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.

Response from Central Manchester University Hospitals NHS Trust (PDF)
Central Manchester University Hospitals INHS|

NHS Foundation Trust
Trust Headquarters
Cobbett House
Manchester Royal Infirmary
Manchester M13 9WL
Tel No: 0161 276 4755
Fax No: 0161 272 6931

29" November 2016

Ms F Borrill

HM Area Coroner
Manchester City Area
HM Coroner's Office
PO Box 532
Manchester Town Hall
Albert Square
Manchester

M60 2LA

—\
[PAs
RECE

IVED
02 220 206

sen eT

Dear Ms Borrill

Re: Inquest touching the death of Amelia Calvo

| am writing in response to your letters of 18 May and 26 October 2016
regarding this matter. | would like to apologise for the delay in responding to
your initial letter.

Point 1

Request for advice on how competing requirements to attend meetings
at lunchtime and be present for Team Briefings for afternoon surgery
can be put into effect so that patient safety is not compromised

Work has been undertaken in RMCH to ensure clinical engagement with the
Team Brief:

s The list used within the Team Brief was revised to address potential
gaps in the original Brief and piloted. This work was clinically led and
was rolled out to the CEPOD Theatre in June 2016 and is now used in
all RMCH Theatres. This includes:

o an Introductions Board has been implemented which includes a
check of the box on the Team Brief board supporting the presence
of all involved staff including the Lead Operating Surgeon and
Anaesthetist

o increased relevance for clinical staff with changed order of items
within the Team Brief (surgical and anaesthetic plan are now
discussed at the start of the Team Brief) and more room on the
board for the ‘Any Problems’ section

. Operating Surgeon for the procedure; if the Operating Surgeon is not
present the patient will not be sent for. Within working hours the
presence of key staff (including the Operating Surgeon) has improved;
out of hours (nights and weekends, when the Operating Surgeon may
not be resident on the hospital site) issues can arise with the attendance
of the Operating Surgeon; advice is that the patient must not be sent for
until the Team Brief has taken place with the Operating Surgeon present

The team who have led on the above changes continue to review this on a
regular basis.

Point 2

Re ere caused considerable distress by the use of the
word ‘outcome’ in the High Level Investigation report. HM Area Coroner
was told this referred to the fact that Amelia would have died in the
future in any event of the, at that stage, undiagnosed Edwards
Syndrome but EE one of the investigation team, did concede that
the use of the word ‘outcome’ was insensitive in all the circumstances

Our understanding, through discussion and following receipt of a letter of
complaint from Amelia’s parents (dated 13.06.16), was that the concern
related to the following wording in the conclusion of the report:

‘These deficiencies should be urgently addressed in order to
avoid recurrence of these events in future, in a situation which
is likely to have more clinical significance’

HE complaint stated ‘no parent should have to read that their
child is not clinically significant’.

In the response Tim complaint (dated 30.08.16), it was
acknowledged that the phraseology was insensitive and that we were deeply
sorry that this was not identified by anyone involved in the production and
checking of the HLI report.

Point 3

Evidence that Mortality and Morbidity team meetings in the Paediatric
Anaesthetic Department were not minuted. It is understood that those
meetings are now minuted and the minutes circulated to clinicians.
Request for confirmation of this

From January 2017, the Paediatric Anaesthetic Department’s discussion of
Mortality and Morbidity will take place as part of the agenda within the Trust
wide Audit and Clinical Effectiveness (ACE) Days. These dates are planned
in —_— le by the cancellation of elective
activity. , Clinical Lead — Theatres and Anaesthesia,
has confirmed that when mortality and morbidity cases are discussed,

summary notes will be provided to capture responses, recommendations,
action plans or outcomes.

Anaesthetic deaths are rare, and the ACE day is considered an appropriate
forum for a departmental discussion of mortality and morbidity. It is important
to highlight that in addition, Royal Manchester Children’s Hospital has a well-
established Mortality Group whereby the final episode of care is reviewed by a
Consuitant who was not invoived in the patient’s care. These meetings are
minuted and the minutes are circulated (to reviewing members and Consultant
medical staff identified as involved during the patient’s final episode of care at
RMCHh).

If you need any further information, please do not hesitate to contact me.

Yours sincerely

WB,

Sir Michael Deegan
Chief Executive

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