Manufacturer's investigation conclusion: review of the submitted log files confirmed low flow alarms.Although a specific cause for the low flow events could not be conclusively determined through this evaluation, the account reported that the patient experienced cardiac arrest at the time of this event.A direct correlation between the device and the reported cardiac arrest could not be conclusively established through this evaluation.The submitted system controller log file captured intermittent low flow alarms, as well as a pump stop due to a driveline disconnect on 24jun2022.Of note, elevated pulsatility index (pi) values were recorded during the low flow events.The pump appeared to have ramped up to the set speed without issue following driveline reconnection and appeared to have operated as intended at the set speed before and after the pump stop.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas).No further events have been reported at this time.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricle assist system (lvas) instructions for use (ifu) is currently available.Section 4, ¿system monitor,¿ explains that the low flow hazard alarm occurs when pump flow is less than 2.5 liters per minute (lpm).A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Changes in patient conditions can result in low flow.Section 7, ¿alarms and troubleshooting,¿ explains all system alarms and the recommended actions associated with them.The heartmate 3 lvas patient handbook also outlines all system controller alarms as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.
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