Complaint Number: 2023-01678 Hospital:

Brighton and Sussex University Hospitals NHS Trust

Brighton Event Occurred Summary On 21 March 2023,

LivaNova received a report of an incident involving a LivaNova medical device at Brighton and Sussex University Hospitals NHS Trust. The reporting hospital stated that on the same day multiple alarms occurred on HLM S5 perfusion system during a procedure and blood circulation was stopped for approximately 14 minutes. The patient passed away 10 days later.

Brighton and Sussex hospital perfusion circuit The Hospital used a CP5 centrifugal pump and LivaNova understands that the setup included the flowmeter between the CP5 centrifugal pump and the oxygenator with the bubble sensor located in the arterial line before the ERC clamp.

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Technical Service Assistance Following notification of the incident, a LivaNova field service engineer was dispatched to the hospital. The CP5 and the ERC were inspected without finding any deviations. As a precaution, the ERC clamp and CP5 panel were replaced and removed for further investigation by LivaNova. In addition, the pump drive, flow module and sensor were also retained by LivaNova. LivaNova's complaints database indicates that since its installation in 2011, no other issues have been submitted for the ERC clamp (SN:60S16179).

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Two different log files were recovered and analysed: - CP5 log file: this log stores only technical error messages related to the CP5 centrifugal pump system and the ERC if connected. - Connect Serdat file: this log records all clinical events (e.g. flow values, bubble, pressure, level alarms, clamp status) Connect receives from its interface.

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In summary, the log files indicate that the ERC clamp functioned as expected until 11:41:28 when, after the level alarm cleared, the clamp didn’t open automatically as expected. The ERC timeout was registered in the CP5 Log file and the ERC would no longer have been operable using the electronic control panel and would have required manual intervention in accordance with the IFU.

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Inspection of the removed CP5 control panel, pump drive, flow module and sensor did not reveal any functional issue with the returned parts. ERC visual inspection The ERC clamp was opened revealing signs of corrosion. It was surmised that this was likely due to wear and fluid penetration over its lifetime.

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Conclusion

Event reported to LivaNova on 21 March 2023 was related to bypass procedure stopped for about 14 minutes, during when no blood flow was possible. During the event of 21 March 2023, multiple alarms were triggered and recorded by the HLM S5 perfusion system, the first was related to an issue opening the ERC clamp. This was properly identified by the HLM S5 perfusion system which displayed the “Arterial clamp is defective” message on the system panel. Due to the multiple alarms, and lack of scrolling in accordance with the IFU, this error was only recognized by the user after a period of delay. Analysis of the available diagnostic real-time data confirms that the ERC became inoperably when in the closed position which may have led to the other alarms being triggered by the system. Analysis of post-market data has not identified any similar event occurring worldwide during more than 5 million performed procedures. The investigation has determined that the root cause of the ERC becoming inoperable was reduced performance of lubricant in the ERC Clamp motor related to wearing as consequence of age and apparent liquid penetration.

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