Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the report of events, as well as the patient¿s outcome, could not be conclusively established through this evaluation.There was no autopsy performed.And the device was not explanted for evaluation.Multiple requests for additional information were sent to the account.However, no additional information was provided.The relevant sections of the device history records for (b)(6) were reviewed, and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists sepsis, hepatic dysfunction and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions regarding preventing infection are included in several sections of the ifu, including in section 6 "patient care and management" (under caution! "caring for the driveline exit site", and "controlling infection").Section 6 also provides suggested responses in the event of infection.The heartmate 3 lvas patient handbook provides care instructions regarding preventing infection in several sections, including section 4 ¿living with the heartmate 3¿ (under ¿caring for the driveline exit site¿).The patient handbook instructs the patient to call their hospital contact immediately, if any signs of infection are noticed.No further information was provided.The manufacturer is closing the file on this event.
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