Manufacturer's investigation conclusion: analysis of the submitted log files confirmed low flow alarms.The center reported that left ventricular assist device (lvad) parameters returned to normal range after multiple trabeculae's and papillary muscles were removed from the patient¿s left ventricle.Theses reported peripheral thrombus formations could not be confirmed through this evaluation.A direct correlation between the other reported events (cardiac arrhythmia, hypertension, hypovolemia) and heartmate 3 left ventricular assist system (hm3 lvas), serial number (b)(6) could not be conclusively established through this evaluation.The center submitted system controller and lvad log files for review (refer to attached).The system controller event log file contains data from 08nov2020 at 18:26:30 through 11nov2020 at 12:38:40.Multiple low flow events were captured on (b)(6) 2020 and (b)(6) 2020, resulting in 18 total low flow alarms.Calculated average flow ranged from 2.2-2.4 lpm for these events.Overall, calculated average flow ranged from 2.2-4.2 lpm.No additional atypical events were captured throughout the file.The pump operated as intended at the set speed.The center reported that the patient was admitted on (b)(6) 2020 with dyspnea.The full investigation process identified high arterial pressure and atrial flutter with partial hypovolemia as the reason for the dyspnea.Rv (right ventricular) function was ok and there were no signs of hemolysis.An echo (echocardiogram) showed suspect objects close to the inflow cannula.The patient¿s high blood pressure was stabilized, but due to the suspected thrombus formation with the inflow cannula, cardioversion was not performed due to the high risk.Iv (intravenous) heparin was started.It was later reported that the patient underwent a revision of the lvad system on (b)(6) 2020 ¿ from the left ventricle, multiple trabeculae's and papillary muscles were removed.An intraoperative echo reportedly confirmed elimination of the suspected anatomical structures that were limiting lvad unloading.After de-airing and cpb (cardiopulmonary bypass) weaning, lvad parameters were in the normal range as expected.The patient remains ongoing on hm3 lvas, serial number (b)(6) and no additional complaints have been reported at this time.The hm3 lvas instructions for use (ifu) lists hypertension, cardiac arrhythmia, and peripheral thromboembolic events as adverse events that may be associated with the use of the hm3 lvas.The ifu also lists hypovolemia and thromboembolism as potential late postimplant complications, and provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.This ifu provides an explanation of all pump parameters, including pump flow.The ifu states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow.The ifu also explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.This document describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.
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