Manufacturer's investigation conclusion: the report of the driveline disconnect event could not be confirmed as no log files were submitted for evaluation.Additionally, a specific cause for the reported events and patient outcome, as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively determined through this evaluation.It was reported that an autopsy was not conducted and heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), would not be returned for evaluation.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 lvas patient handbook, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including cardiac arrhythmia and death, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 2 of the ifu, "system operations" (under "system controller warnings and cautions"), states "check the system controller driveline connector to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump stops.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation." additionally, section 2 of the ifu, under "connecting the driveline to the system controller", provides instructions on connecting/disconnecting the driveline to/from the system controller and making sure that it is fully and properly inserted into the system controller socket.The ifu states to power the replacement system controller by connecting both the white and black power connections, prior to exchanging system controllers.Section 2 of the patient handbook, ¿how your heart pump works¿, also advises the user to ¿check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump will stop.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation¿.The patient handbook also explains that the pump cannot run without power.Always ensure that the power cables are connected to a power source to ensure the heartmate 3 pump will restart during a controller exchange.This handbook provides instructions on how to exchange system controllers and states, ¿do not attempt to change your system controller without having a trained, competent caregiver at your side to assist.Follow all alarm instructions, including calling the hospital if instructed.¿ section 6 of the ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication.Furthermore, section 5 of the patient handbook, "alarms and troubleshooting", and section 7 of the ifu, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.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 24apr2019.No further information was provided.The manufacturer is closing the file on this event.
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