Prevention of Future Deaths reports · 2020

Malyun Karama

Regulation 28 report to prevent future deaths, reference 2020-0162, written 21 Aug 2020. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report21 Aug 2020
Reference2020-0162
DeceasedMalyun Karama
CoronerMary Hassell
Coroner areaInner North London
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedRoyal Free London NHS Foundation Trust
Sourcejudiciary.uk record · original PDF
Responses published1

The report

Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.

Regulation 28:  Prevention of Future Deaths report 

Malyun Habib KARAMA (died 20.02.20) 

THIS REPORT IS BEING SENT TO: 

1.  Dr 

Medical Director 
Royal Free Hospital 
Pond Street 
London  NW3 2QG 

1 

CORONER 

I am:   Coroner ME Hassell 
           Senior Coroner  
           Inner North London 
           St Pancras Coroner’s Court 
           Camley Street 
           London  N1C 4PP 

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 26 February 2020, I commenced an investigation into the death of 
Malyun Karama, aged 34 years. The investigation concluded at the end 
of the inquest on 12 August 2020. I made a narrative determination at 
inquest, which I attach. 

4 

CIRCUMSTANCES OF THE DEATH 

Malyun Karama died at the Royal Free Hospital from a uterine rupture 
caused by the administration of misoprostol prescribed to induce labour 
following  a  diagnosis  of  intrauterine  death.    The  misoprostol  was 
administered  at doses  in  excess  of the  Royal College  of  Obstetricians 
and Gynaecologists national guidelines. 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Abnormal observations were relayed by a midwife to a senior registrar, 
but the doctor failed to attend Ms Karama and instead ordered fluids. 

The uterine rupture would have been life threatening whatever the care 
rendered to Ms Karama, but if the doctor had attended immediately and 
had  reviewed  and  treated  appropriately,  the  likelihood  is  that  Ms 
Karama’s life would have been saved. 

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  heard  evidence  of  changes  in  systems  at  the  Royal  Free  Hospital 
following  the  events  of  20  February  2020,  including  changing  the 
misoprostol  dose  protocol  and  making  a  medical  review  mandatory 
before each administration to a multi gravida mother. 

However, the Royal Free has not yet taken any steps to ensure that there 
is learning at a national level of the increased risk of rupture in a multi 
gravida  mother.    The  more  widely  known  increased  risk  is  simply  of 
vaginal birth after caesarean. 

Also, one of the midwives looking after Malyun Karama explained that 
there was no computer in the delivery suite and so she could not record 
her observations contemporaneously or without leaving the room.  This 
is sub optimal. 

6 

ACTION SHOULD BE TAKEN 

In  my  opinion,  action  should  be  taken  to  prevent  future  deaths  and  I 
believe that 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 19 October 2020.  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. 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 8 

COPIES and PUBLICATION 

I have sent a copy of my report to the following. 

  HHJ Mark Lucraft QC, the Chief Coroner of England & Wales  
  Mr 

, Malyun Karama’s husband 

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 Senior Coroner, at the time of your response, 
about  the  release  or  the  publication  of  your  response  by  the  Chief 
Coroner. 

9 

DATE                                                  SIGNED BY SENIOR CORONER 

21.08.20                                              ME Hassell 

3

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 Royal Free London NHS Foundation Trust (PDF)
8 October 2020 

BY EMAIL ONLY 

HM Coroner ME Hassell 
Senior Coroner 
Inner North London 
St Pancras Coroner’s Court 
Camley Street 
London N1C 4PP 

Dear Madam, 

Response to Regulation 28 Prevention of Future Deaths Report – Malyun KARAMA 

I have set out within this letter and in the action plan and documents attached, the Trust’s responses 
to the Matters of Concern that you have brought to our attention in your Regulation 28 Prevention of 
Future Deaths Report dated 21 August 2020.  I have been assisted in compiling the Trust’s responses 
by: 

  Dr 
 
  Dr 
 

, Clinical Director of Obstetrics and Gynaecology   
, Head of Midwifery  

, Consultant Obstetrician & Service Line Lead for Obstetrics 

, Head of Quality Governance 

I have set out below each of the Matters of Concern followed by the Trust’s responses: 

1.  Evidence was heard at the inquest of changes in systems at the Royal Free Hospital following 
the events of 20 February 2020, including changing the misoprostol dose protocol and making 
a medical review mandatory before each administration to a multi gravida mother. However, 
the Royal Free had not yet taken any steps to ensure that there was learning at a national level 
of the increased risk of rupture in a multi gravida mother. The more widely known increased 
risk is simply in vaginal birth after caesarean.  

2.  Evidence was heard at the inquest that there was no computer in the delivery suite and so the 
midwife could not record her observations contemporaneously or without leaving the room 
which was found to be sub-optimal.  

1.  Learning at a national level of the increased risk of rupture in a multi gravida mother 

Please  refer  to  the  attached  action  plan  item  (1d)  and  documents,  which  can  be  summarised  as 
follows: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 The Actions required are: 

  For  the  case  to  be  presented  at  the  NCL  (North  Central  London)  Local  Maternity  System 

Quality and Safety Meeting. This is set to take place on 6 November 2020. 

  Learning  in  relation  to  the  increased  risk  of  rupture  in  relation  to  multigravida  women  to  be 
shared  with  the  national  maternity  risk/governance  managers  email  distribution  forum.  This 
was completed on 2 October 2020 and the email that was distributed has been embedded into 
the attached action plan. 

  Learning  from  the  incident  to  be  shared  with  the  Project  Manager  for  the  Maternity  Clinical 
Network – NHS England and NHS Improvement – London Region. This was completed on 2 
October 2020 and the email that was distributed has been embedded into the attached action 
plan. 

2.  Ensure a computer is in the delivery suite to enable contemporaneous note-keeping 

Please refer to the attached action plan item 2 and document, which can be summarised as follows: 

The Action required is for a review to take place of the workstations on wheels (WOW) on the Labour 
Ward to ensure that all Labour rooms possess a computer for staff use.  

This  review  was  completed  on  2  September  2020  and  it  identified  that  there  were  the  appropriate 
number  of  workstation  on  wheels  for  the  Labour  rooms.  However  it  was  identified  that  staff  were 
removing the Wow carts from the Labour rooms. This gave rise to recommendations being sent out via 
email on 2 September 2020 that: 

1.  The Wow carts should not be removed from the delivery room; 
2.  If the Wow carts are not working, the staff member: should 

- 

speak to the  labour  ward  co-ordinator  in  order  to check  this  and to  check that  the  cables 
are correctly placed; 
reported it to the IT helpdesk. 

- 
-  Log an incident on our Datix system to ensure the issue is investigated. 

Thank you for bringing these matters to the Trust’s attention and providing us with an opportunity to 
further review  and  improve our  processes.  The Trust  is  continuously  seeking to  improve  the quality 
and safety  of  the care that  it  provides  to its  patients  and  your  Preventing  Future  Deaths  Report has 
been a helpful contribution to this ongoing and extremely important process. 

Yours sincerely, 

Dr 
Medical Director, Barnet Hospital   

,  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Royal Free London NHS Foundation Trust – Response To Prevention of Future Deaths Report: Action Plan 

Report from: 

Medical Director (Barnet Hospital Business Unit) 
Clinical Director of Obstetric and Gynaecology  (Royal Free Hospital) 
Head of Midwifery (Royal Free Hospital) 
Obstetric Lead (Royal Free Hospital)  

Author(s) 
Date 

Head of Quality Governance 
02/10/2020 

Background 

The purpose of this report is to summarise the actions the Royal Free London NHS Foundation Trust has taken and intend to take in order to address 
the Regulation 28: Prevention of Deaths report issued against the Trust on 21 August 2020 following the inquest into the death of  Mrs MK (MRN 
20055715) at the Royal Free Hospital on 26 Februaruy 2020.  

The Prevention of Death report highlighted the following Matters of Concern: 
‘I heard evidence of changes in systems at the Royal Free Hospital following the events of 20 February 2020, including changing the misoprostol 
dose protocol and making a medical review mandatory before each administration to a multi gravida mother.  
However, the Royal Free has not yet taken any steps to ensure that there is learning at a national level of the increased risk of rupture in a multi 
gravida mother. The more widely known increased risk is simply of vaginal birth after caesarean.  
Also, one of the midwives looking after MK explained that there was no computer in the delivery suite and so she could not record her 
observations contemporaneously or without leaving the room. This is sub optimal.’  

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Action plan 

No.  Matters of 

Concern 

Action (required to address the 
Matter of Concern) 

1. 

‘I heard evidence of 
changes in systems 
at the Royal Free 
Hospital following 
the events of 20 
February 2020, 
including changing 
the misoprostol 
dose protocol and 
making a medical 
review mandatory 
before each 
administration to a 
multi gravida 
mother. However, 
the Royal Free has 
not yet taken any 
steps to ensure that 
there is learning at 
a national level of 
the increased risk 
of rupture in a multi 
gravida mother. 
The more widely 
known increased 
risk is simply of 
vaginal birth after 
caesarean.  

a.  The Bereavement/Pregnancy 
Loss guideline updated to 
include the following and 
disseminated via the Trust 
intranet: 

-  The regimen for Misoprostol 
to be in line with national 
guidance 

-  Clear guidance on the 

dosage for women receiving 
misoprostol for induction of 
an intrauterine death 
depending on their parity. 
The change should be as 
follows: If a woman is 
administered vaginal 
misoprostol after 26 weeks 
the dosing needs to be every 
6 hours rather than every 4 
hours. Once the woman 
begins to contract after 
having been given 
misoprostol, she should have 
an obstetric review prior to 
any further dose of 
misoprostol being given.  
-  New guidance outlining the 
medication dosages  for 
termination of pregnancy 
which are different to those 
for intrauterine death. 
-  To develop an e-learning 
package to reflect the 
changes to the guideline. 
-  To share the learning at the 

Responsibility 
(Person who has 
agreed to take action 
forward: job title)  
Obstetric Lead  

Action Deadline 

Evidence (that will prove 
action is completed) 

Status of the Action 

Revised Bereavement/ 
Pregnancy Loss guideline 
– April version 

Revised Bereavement/ 
Pregnancy Loss guideline 
– September version 

New guidance to be 
disseminated as part of 
junior doctor teaching 
and an e-learning 
package for all midwifery 
and obstetric staff 
currently under 
development. 

Screenshot of the updated 
guideline on the intranet 

Attendance log of junior 
doctor teaching as 
evidence 

Email communication of 
the e-learning package. 

Bereavement/Pregnancy 
Loss guideline updated 
and approved by the 
Women Services 
Guideline Group – 
Action completed April 
2020 

Further amendments 
made to the  
Bereavement/Pregnancy 
Loss following the inquest 
on 12 August 2020 – 
revised guideline 
uploaded to the intranet – 
Action completed 30 
September 2020. 

E-learning package - 
Deadline for completion 
of action 5 October 
2020. 

Junior doctor teaching – 
Deadline for completion 
of action 30 October 
2020. 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Junior doctor teaching. 
b.  A memo to be sent to staff of 

the changes to the 
Bereavement/Pregnancy Loss 
guideline. 

Obstetric Lead  

Action completed - 28 
August 2020 

Memos sent to staff 

c.  Spot check  of compliance with 

the new regimen for 
Misoprostol to be undertaken 
by the Bereavement midwives 
for a three-month period to 
ensure this practice is 
embedded. This will be 
performed over two months 
due to the small numbers of 
cases. 

d.  Learning from the incident to 
be shared on a national basis 
via the following: 

- 

-  The case to be presented at 
the NCL Quality Safety 
meeting on 6 November 2020. 
Learning in relation to the 
increased risk of rupture in 
relation to multigravid women 
to be shared with the national 
maternity risk/governance 
managers email distribution 
forum. 
Learning from the incident to 
be shared with the Project 
Manager for the Maternity 
Clinical Network - NHS 
England and NHS 
Improvement – London 

- 

Bereavement 
Midwives  

31 December 2020 

Results from the spot 
checks of compliance with 
the new regimen for 
Misoprostol 

Head of Quality 
Governance  Barnet 
Hospital Business 
Unit  

NCL Quality and Safety 
meeting presentation of 
the case - 
6 November 2020 

Minutes from the NCL 
Quality and Safety meeting 
Powerpoint Presentation of 
the case 

Email communication to 
the national maternity 
risk/governance 
managers - Action 
completed 2 October 
2020 

Email communication to 
the Project Manager for 
the Maternity Clinical 
Network - NHS England 
and NHS Improvement - 
London Region - Action  
completed 2 October 

Email communication to 
the national maternity 
risk/governance managers 
email distribution forum. 

Email communication to 
the Project Manager for the 
Maternity Clinical Network - 
NHS England and NHS 
Improvement – London  
Region 

Initial memos sent to staff 
on  at the time of the 
incident and the initial 
revision of the guideline 
on  the 30 March 2020 
and 29 May 2020. 

A further memo was sent 
to staff with the additional 
amendments to the 
guideline on 28 August 
2020. 

3 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Head of Midwifery  

2020 
Action completed - 2 
September 2020 

Memo to staff 

2.  Also, one of the 

midwives looking 
after MK explained 
that there was no 
computer in the 
delivery suite and 
so she could not 
record her 
observations 
contemporaneously 
or without leaving 
the room. This is 
sub optimal.’  

Region. 

To review the workstations on 
wheels available on the Labour 
ward to ensure that all Labour 
rooms possess a computer for staff 
use. The review to inform the 
actions to be taken. 

Review completed – The review 
identified that there were the 
appropriate number of workstation 
on wheels for the Labour rooms – 
however it was identified that staff 
were removing the WOW carts 
from the Labour rooms. 

Review completed – The 
review identified that 
there were the 
appropriate number of 
workstations on wheels 
(WOW) for the Labour 
rooms – however it was 
identified that staff were 
removing the WOW carts 
from the Labour rooms. A 
memo sent to staff on 2 
September 2020. 

4

Related reports

Other reports by Mary Hassell

See all →

More reports categorised “Hospital Death (Clinical Procedures and medical management) related deaths”

See all →

Track Royal Free London NHS Foundation Trust

See every Prevention of Future Deaths report matching Royal Free London NHS Foundation Trust, and how often a new one appears.

What would an alert for this have sent me? Search the full text

Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.

These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.