Manufacturer's investigation conclusion a direct relationship between the device and the root cause for the heart transplant could not be conclusively determined through this investigation.No alarms were associated with the event.The device was retained by the hospital and will not be returned for evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 1 ¿introduction¿ of this document lists adverse events that may be associated with the use of the heartmate 3 lvas.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 17oct2019.No further information was provided.The manufacturer is closing the file on this event.
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