PERFUSION REPORTS

REPORT

123

DATE

5/7/2024

TITLE

Hardware Fault

DETAILS OF INCIDENT

Duringa routine bypass case for isolated AVR the main roller pump suddenly stopped.The speed controller green LED indicator lights stayed at the previouslyindicated rpm level, the touchscreen was unresponsive.

This happened 3 times during the case at different intervals.

DETAILS OF INJURY TO PATIENT

No Harm

TYPE OF DEVICE/MANUFACTURER

LivaNova S5

‍

ACTION TAKEN

In the first instance the speed controller knob was quickly turned down to 0 rpm and then back up to the appropriate level, bypass was re-established with little delay. The same action was taken at the 2nd occurrence of the same issue. On the 3rd occurrence the single pump module was turned off and back on again, bypass was re-established, with no subsequent recurrence, the patient was separated from bypass at the conclusion of the surgery without incident. The pump module was then taken out of service, and the manufacturer informed.

‍

RESPONSE FROM MANUFACTURER

LivaNova interrogated the pump history and decided that the cause was a fault in the touchscreen, which was duly replaced. It was put back in service and has been functioning normally since then.

‍

ADDTIONAL INFORMATION

The safety committee reviewed the incident. It is essential as part of the QMF that equipment is maintained and serviced and faults communicated. We thanks the reporter for highlighting this issue.

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