June Liddell

Dear Ms Andrews 
Regulation 28 Report, dated 13 January 2025 – Re June LIDDELL (deceased) 

06 March 2025 

We write in response to your Regulation 28 Report, dated 13 January 2025, sent following the conclusion of the 
inquest into the death of June Liddell on 1 April 2023. 
We would like to take the opportunity again to express our condolences to Mrs Liddell's family. 
Following careful consideration of the matters raised in the Regulation 28 Report, together with the evidence 
raised during the course of the inquest including the  hearing held on  6 and 7 January 2025,  we respectfully 
provide the following responses to the Matters of Concern. 

Background and history of the S5/CP5 

The LivaNova S5 has been used by the perfusion community for almost 20 years. Between January 2020 and 
December 2024, the CP5 (with ERC clamp) was used in more than 6.8 million operations.  During that period, 
there has been only one incident of serious injury or death associated with the ERC clamp.  Sadly, that was the 
unfortunate case of Mrs Liddell to which the Regulation 28 Report relates. 
As a global medical device manufacturer, LivaNova develops innovative products that deliver life saving devices 
for patients, and the approach to quality starts and ends with patient and customer safety. LivaNova’s Quality 
Management System ("QMS") is designed to build quality into products at every stage of the lifecycle, starting 
from the design and development through manufacturing, testing, distribution, and post-market surveillance. As 
part of the QMS, LivaNova's Corrective and Preventative Actions program embeds a robust process to identify 
potential  issues  and  to  take  action  to  resolve  them.  The  risk  management  process  follows  the  ISO  14971 
international  standard  for  medical  devices  which  ensures  the  safety  and  effectiveness  of  the  devices  for  the 
intended use.  
We  monitor  the  use  and  performance  of  our  products  distributed  to  the  market  through  the  post  market 
surveillance system by gathering data from customer feedback collected through our global complaint handling 
process  and  via  medical  and  clinical  literature  review  and  post-market  clinical  data  collection  activities,  with 
information shared and communicated to customers, patients, and internally via the risk management process. 
When  alerted  of  potential  safety  concerns  in  the  market,  LivaNova  takes  immediate  actions  through  the 
embedded QMS correction and removal process to ensure patient safety. 

Matters of concern 

The Regulation 28 Report includes three matters of concern, being: 

1. 

the error message "Arterial clamp is defective" is not included in the Instructions for Use ("IFU") for the 
SP5 or ERC clamp; 

2.  The SP5 and ERC clamp IFUs do not specify that the disappearance of the icons for the control of the 

ERC clamp is indicative of a defect with the ERC clamp; and 

3.  Manufacturers maintenance of the machine does not include a process to identify when an ERC clamp 

is experiencing wear and tear. 

Error message 

The "Arterial clamp is defective" error message is displayed on the CP5 System Panel and is unmistakable and 
readily understood. It directly describes the issue that is occurring. No additional explanation is necessary or 
helpful in order to allow a certified perfusionist to understand that there is a functional issue with the ERC clamp 
which needs to be investigated. 
The  error  message  is  persistent  and  remains  in  place,  albeit  that  in  the  event  of  multiple  error  messages 
appearing, the messages scroll off the front page but can still be checked by using the scroll button function.   
The scroll function is a well-known feature of the CP5 System Panel1 and is described in the IFU 2.   
As such, there is no basis for a certified perfusionist not to see the error message if it is displayed. Once seen, 
it is obvious that there is an issue with the ERC clamp requiring investigation.  No further instructions are needed 
to describe the error in order to allow any issue to be considered and rectified. 

1 Bundle reference G581 – paragraph 4.20 
2 Bundle reference G125 – section 5.3.1. 
LivaNova Deutschland GmbH 
Lindberghstrasse 25 
D-80939 München 

T +49 (0)89 323 01 0 
F +49 (0)89 323 01 100 
www.livanova.com 

Amtsgericht München 
HRB 100852 
USt-IdNr. (VAT): DE 129304291 
Steuer-Nr: 143/181/70429 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Disappearance of the icons 

The clamp icons being displayed on the CP5 Control Panel allows a certified perfusionist to see the status of 
the ERC clamp, and to operate it manually by pressing the relevant 'open' or 'close' icon. 
A lack of icons necessarily indicates that the ERC clamp is not engaged or assigned – it is unavailable for use. 
If the ERC clamp is installed then the lack of icons indicates to a perfusionist that immediate investigation of the 
ERC clamp is required since it can no longer be operated from the CP5 Control Panel.  
As noted above, during normal operation of the CP5, a perfusionist will open the ERC clamp manually from the 
Control Panel using the relevant touchscreen icon following resolution of certain alarm situations, e.g. a bubble 
alarm. 
If no icons are showing, it is obvious to certified perfusionists that the ERC clamp is not engaged in the system, 
cannot be operated from the Control Panel and therefore the ERC clamp requires further investigation.  This 
need to investigate the ERC clamp is reinforced by the clear error message described above being displayed at 
the same time as the icons disappear from the screen. 

Incident in question 

LivaNova understands that in the incident case the CP5 acted entirely as intended when an issue was detected 
with the ERC clamp.  It both displayed the relevant error message as described above and removed the icons 
from  the  CP5  Control  Panel.    Each  of  those  independently  would  have  alerted  a  perfusionist  to  the  need  to 
investigate the ERC clamp immediately.  Such an investigation would necessarily have included opening the 
clamp cover. 
LivaNova further understands that the evidence presented at the inquest was that there was a further indication 
of an ERC clamp issue in that forward flow could not be re-established.   
Failure  to  re-establish  forward  flow  was  a  clear  and  independent  indication  to  a  perfusionist  that  there  is  a 
blockage  requiring  investigation.    The  evidence  at  the  inquest  was  that  such  an  investigation  did  take  place 
immediately but crucially – and inexplicably – did not include consideration of the ERC. 
LivaNova cannot explain why – in circumstances where there was: 

i. 
ii. 
iii. 

a visible alarm message3; 
disappearance of the ERC clamp icons; and 
an inability to re-establish forward flow;  

the perfusionist failed to consider the ERC clamp, despite undertaking an inspection to identify an obstruction. 
That inspection should have necessarily included the ERC clamp on the basis it is designed to and operates as 
a device to prevent flow on the arterial line. 
It is of note that the evidence of the perfusionist was that: "I checked again verbally/visually with Mr [redacted] 
to rule out any obstruction upward on the arterial line circuit. I then instantly and instinctively released the ERC… 
with forward systemic flow restored." 4 
It is also apparent from his witness statement that the Consultant Cardiothoracic Anaesthetist and Intensivist, 
on  noticing  the  lack  of  icons5,  prompted  an  investigation  of  the  CP5  control  panel  error  messages  and  the 
opening of the ERC clamp. 
From the above, it is clear that any one of the three indicators alone (alarm, disappearance of the icons and 
failure to establish forward flow) is sufficient to lead a perfusionist to follow their training to identify a blockage 
which includes considering, and opening, the ERC clamp within moments.  
This  conclusion  is  supported  by  the  expert  perfusionist  you  instructed,  who  stated  "[c]ritically  though,  the 
information  that  ultimately  identified  the  electronic  clamp  as  the  source  of  the  problem  was  there  from  the 
beginning" 6.    His  view  accords  with  that  of  LivaNova's  which  is  that  the  perfusionists  failed  to  act  on  the 
information that was properly provided by the CP5. The extensive safety record of the CP5 further demonstrates 
that to be the case with only a single incident of harm recorded across over 6.8 million uses. 

IFUs 

IFUs are not reference items and are not intended to be referred to in emergency situations. As noted at section 
1.1 of the Operating Manual, the operating instructions "are solely intended for qualified perfusionists".  Indeed, 
clinical perfusion procedures can only be undertaken by an accredited Clinical Perfusion Scientist and therefore 

3 Machine log evidence suggests that it would not have scrolled off the display for at least 3 minutes from when it was initially displayed. 
(Bundle reference G35 – paragraph 5.7(d)) 
4 Bundle reference G16 – paragraph 23. 
5 Bundle reference G5 – paragraph 5. 
6 Bundle reference G595 - paragraph 6.24 
LivaNova Deutschland GmbH 
Lindberghstrasse 25 
D-80939 München 

T +49 (0)89 323 01 0 
F +49 (0)89 323 01 100 
www.livanova.com 

Amtsgericht München 
HRB 100852 
USt-IdNr. (VAT): DE 129304291 
Steuer-Nr: 143/181/70429 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 there is a high degree of relevant training and knowledge of a qualified user.  The IFU is written for those intended 
users, being trained perfusionists, for whom the automatic reaction to the error message is to investigate the 
cardiopulmonary bypass circuit, including the ERC clamp, and to clear any blockage.  The error message and 
lack of ERC clamp icons are two independent identifiers which direct a perfusionist to investigate the arterial 
clamp specifically.  No additional wording in the IFU would or indeed should, change that response. 
The fact that this is the only patient death or serious injury that has arisen following a failure of the ERC clamp 
underlines the view that all perfusionists are trained to automatically check for blockages, including in the ERC 
clamp, and to clear them and that the operation of the CP5 in the extremely rare event of a failure is clear and 
appropriate to mitigate the risk of serious injury or death. This is reaffirmed by the statistics which show that in 
the period from January 2020 to December 2024, during more than 6.8 million uses only one, being the present 
tragic incident, has involved patient harm (1 in 6.8 million = 0.000015%).  
Accordingly, from the evidence in relation to the present incident, it is clear that the tragic incident involving Mrs 
Liddell should have been avoided.  
No  additions  to  the  IFUs  would  have  prevented  the  tragic  situation  encountered  in  this  incident  since  the 
perfusionist for unknown reasons did not follow their training, ignored the clear and obvious warning signs, and 
failed to immediately resolve the obstruction as they should have done. 

Maintenance 

The IFU for the ERC is clear that "Liquids must not enter the housing. Therefore, do not use sprays" and further 
states "Ensure again that no liquids enter the housing".7 
In this specific case the device functionality was impacted by infiltration of liquids during the 12 years of previous 
ERC clamp use.  Such liquid infiltration is not addressable by standard maintenance because the ERC clamp is 
a closed unit intended to operate for its expected service lifetime.  
The  observed  failure  rate  of  the  ERC  clamp  (being  155  in  6.8  million  =  0.0023%)  is  such  that  a  properly 
maintained ERC clamp in accordance with the IFU does not warrant a specific maintenance schedule to identify 
instances of wear and tear caused by a failure to follow the IFU in relation to cleaning and disinfection.   
Even in the incredibly rare instance of an ERC clamp failure, the device is safe.  The CP5 will properly indicate 
to the trained perfusionist that the ERC clamp has failed (alarm and lack of icons) which together with a failure 
to re-establish forward flow will necessarily lead to all perfusionists immediately and automatically checking for 
blockages, including in the ERC clamp, and to clear them as per their training. 
Accordingly, there is no proper basis to support a conclusion that the existing standard maintenance procedures 
in relation to the ERC clamp are of concern such that there is a risk of future deaths. 

Conclusion 

It is clear to LivaNova that this tragic incident was avoidable and that the CP5 operated as intended in the event 
of a rare ERC clamp failure.  
The perfusionist was notified by way of a clear and unmistakeable alarm message and removal of functional 
icons.  In addition, the inability to reestablish forward flow – even absent the clear indications of a failure - should 
inevitably have caused the ERC clamp to have been investigated immediately (as ultimately happened) and the 
issue rectified within moments.  Had that been done, no harm would have come to Mrs Liddell.  This view is 
supported by the evidence of the expert appointed to assist the Inquest: 
"What would have taken a competent perfusionist perhaps tens of seconds to a couple of minutes to resolve 
took more than 12 minutes. This was as a direct consequence of the poor decision making of the perfusionists… 
they demonstrated a level of competence that was less than Mrs Liddell rightfully should have expected." 8 
In  light  of  the  above  and  after  careful  consideration,  LivaNova  respectfully  does  not  agree  that  any  drafting 
changes to the IFU would have led to a different outcome in this case. 

Yours sincerely 

Senior Director Customer Quality 

7 Bundle reference G546 – section 5.2 
8 Bundle reference G576 – paragraph 3.8. 
LivaNova Deutschland GmbH 
Lindberghstrasse 25 
D-80939 München 

T +49 (0)89 323 01 0 
F +49 (0)89 323 01 100 
www.livanova.com 

Amtsgericht München 
HRB 100852 
USt-IdNr. (VAT): DE 129304291 
Steuer-Nr: 143/181/70429

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Dear 

and Ms Andrews,

Thank you for notification of the Regulation 28 Report to Prevent Future Deaths
concerning the investigation into the death of June Liddell. The coroner’s concerns
relating to the LivaNova S5 heart lung machine were noted and an MHRA
investigation was commenced to evaluate these concerns.

During the investigation, all available evidence was considered, the issues were
discussed at length with the manufacturer, independent expert opinions were sought
from clinical perfusionists to support next actions, and the matter was presented
multiple times at multidisciplinary MHRA signal meetings where actions were agreed.

With reference to the coroner’s concerns, our investigation concluded that:

 

 

the “Arterial clamp is defective” error message concurrently shown on the
separate CP5 System Panel screen to adequately indicate the issue; 
inclusion in the instructions for use (IFU) of an explanation of the “Arterial
clamp is defective” message and relevant follow up action for the user would
be information that could provide improved user support; 

  and the existing IFU has appropriate precautionary warnings to prevent liquid

ingress damage and wear and tear.

Following extensive correspondence with the manufacturer, our recommendation
was to update the IFU to include an explanation of the “Arterial clamp is defective”
message, along with relevant follow up action for the user. LivaNova have confirmed
that the revised IFUs have been distributed to UK customers, including a customer
letter, which has been published on LivaNova’s website (see “Resources”).

I hope this explains MHRA’s position and actions taken. Please do not hesitate to
contact me if you have any questions.

Kind regards,

Benefit Risk Evaluation Assessor
Safety and Surveillance Group

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU