Manufacturer's investigation conclusion: the report of low flow alarms can be confirmed based on the onsite evaluation by an abbott representative.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.Since the upgrade, no further alarms have been reported.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).The heartmate 3 lvas ifu, rev.C, is currently available.The system monitor section of the ifu describes the pump flow display and pulsatility index (4-12 through 4-16) and the hazard alarms (4-18 and 4-30).This document 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.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm (7-7 and 7-11).This document also provides information regarding anticoagulation, including recommended inr values the heartmate 3 lvas patient handbook, rev.C, is also currently available.Section 5 of this handbook, entitled "alarms and troubleshooting," describes the actions to take in the event of a low flow alarm.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 29oct2021.No further information was provided.The manufacturer is closing the file on this event.
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