Manufacturer's investigation conclusion:
evaluation of the submitted log files confirmed a pump stop event that appeared to be due to open fuses in the system controller.A direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the open fuses could not be conclusively established through this evaluation.The controller event log file contained data from 02mar2022 through 07mar2022.On 07mar2022, a controller internal fault alarm was captured, which was followed by a pump stop event.The pump stop event was associated with a vs b low, vs a low fault, and a driveline disconnect alarm.The driveline disconnect event appeared to be due to the open fuses that were confirmed through the evaluation of the returned system controller.A no external power alarm was also captured on 07mar2022 which appeared consistent with the report of a system controller exchange.No other notable events or alarms were captured.Prior to the fuse damage, there were no notable events or alarms captured and the pump appeared to function as intended at the set speed.The patient remains ongoing on hm3 lvas, serial number (b)(6), and no further events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 07may2019.The heartmate 3 lvas ifu and the heartmate 3 patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.The ifu caution the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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