PFD report

June LIDDELL · Prevention of Future Deaths report

Pin Get email alerts Request correction

Issued 13 Jan 2025•West Sussex, Brighton and Hove

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
2

Raised in this report

Recipients
1

Named on the report

Responses found
2

Of 1 recipient

Stated actions
1

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised2

  1. Instructions for Use failing to identify SP5 and ERC defect indications
    Part of recurring concern: Failure to ensure clear and followed instructions for safe equipment use
  2. Maintenance failing to identify ERC wear and tear
    Part of recurring concern: Failure to ensure essential clinical equipment and supplies are available and serviceable
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. Action

    Investigate the reported heart-lung machine safety concerns and determine appropriate follow-up action.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 16 January 2025.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    The separate CP5 System Panel’s “Arterial clamp is defective” error message adequately indicates the issue.

    Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Instructions for Use failing to identify SP5 and ERC defect indications

Wider context from the report

“I heard that the error message “Arterial clamp is defective” is not one which is included in the Instructions for Use for the SP5 or ERC machine whilst others are explained. As such this message was not one which the Perfusionist community were aware of prior to this incident. The SP5 and ERC instructions for Use documentation does not specify that the disappearance of the icons for the control of the ERC is indicative of a defect with the ERC. The evidence was that this alarm functions in an entirely different way to other alarms on the SP5 system and this was not within the knowledge of any of the Perfusion witnesses that the Court heard from. The Manufacturers maintenance of the machine does not include a process to identify when an ERC is experiencing wear and tear which may indicate that action should be taken. ”

Is this part of a recurring concern?

Yes — Failure to ensure clear and followed instructions for safe equipment use.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Maintenance failing to identify ERC wear and tear

Wider context from the report

“I heard that the error message “Arterial clamp is defective” is not one which is included in the Instructions for Use for the SP5 or ERC machine whilst others are explained. As such this message was not one which the Perfusionist community were aware of prior to this incident. The SP5 and ERC instructions for Use documentation does not specify that the disappearance of the icons for the control of the ERC is indicative of a defect with the ERC. The evidence was that this alarm functions in an entirely different way to other alarms on the SP5 system and this was not within the knowledge of any of the Perfusion witnesses that the Court heard from. The Manufacturers maintenance of the machine does not include a process to identify when an ERC is experiencing wear and tear which may indicate that action should be taken. ”

Is this part of a recurring concern?

Yes — Failure to ensure essential clinical equipment and supplies are available and serviceable.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Investigate the reported heart-lung machine safety concerns and determine appropriate follow-up action.

Verbatim wording from the response

“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.”

Source location

Response from MHRA
Page 1 · response
Published 16 January 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The separate CP5 System Panel’s “Arterial clamp is defective” error message adequately indicates the issue.

Verbatim wording from the response

“• the “Arterial clamp is defective” error message concurrently shown on the separate CP5 System Panel screen to adequately indicate the issue;”

Source location

Response from MHRA
Page 1 · response
Published 16 January 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Existing error messages, icon removal and perfusionist training adequately identify ERC clamp problems, so additional IFU instructions are unnecessary.

Verbatim wording from the response

“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 IFU². 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.”

Source location

Response from LivaNova
Page 1 · response
Published 16 January 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The incident resulted from perfusionists failing to follow clear warnings and training, not from missing IFU wording.

Verbatim wording from the 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.”

Source location

Response from LivaNova
Page 3 · response
Published 16 January 2025

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Standard ERC clamp maintenance is sufficient; its closed design and very low failure rate do not warrant a specific wear-and-tear inspection schedule.

Verbatim wording from the response

“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.”

Source location

Response from LivaNova
Page 3 · response
Published 16 January 2025

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    The existing instructions for use contain appropriate warnings against liquid ingress damage and wear and tear.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The existing instructions for use contain appropriate warnings against liquid ingress damage and wear and tear.

Verbatim wording from the response

“• and the existing IFU has appropriate precautionary warnings to prevent liquid ingress damage and wear and tear.”

Source location

Response from MHRA
Page 1 · response
Published 16 January 2025

Open published response
Back to top

Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026