Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6), and the reported events (ischemic stroke, death, and patient condition) cannot be conclusively determined through this investigation.Low flow alarms were confirmed via the submitted log file data; however, a specific cause for the change in pump parameters cannot be conclusively determined through this investigation.The controller event log file contained data spanning from (b)(6) 2021 at 10:24:41 to (b)(6) 2021 at 09:42:52, per the timestamp.Numerous low flow events were captured on (b)(6) 2021, spanning from 10:25:32 through 11:10:02, when the estimated pump flow was calculated to be below the threshold of 2.5lpm.A total of 6 low flow events persisted for at least 10 seconds, activating low flow alarms.No other notable alarms were recorded, and the pump appeared to have been operating as intended.The account communicated that heartmate 3 left ventricular assist system, serial number (b)(6), had been operating as intended and would not be returned for evaluation as no autopsy was performed.The heartmate 3 left ventricular assist system instructions for use, rev.C, is currently available.Section 1 lists stroke and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 4 describes the pump flow display (4-13 through 4-15) and the hazard alarms (4-19 and 4-32).The instructions for use states that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and explains that changes in patient conditions can result in low flow.Section 6 contains information regarding the recommended anticoagulation therapy and international normalized ratio range.Section 7 describes the actions to take in the event of a low flow alarm (7-7 and 7-11).The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The implant kit shipped on (b)(6) 2020.No further information was provided.The manufacturer is closing the file on this event.
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