Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.Additionally, review of the submitted log file confirmed low flow events; however, a specific cause for these events could not be determined through this evaluation.The controller event log file contained data from (b)(6) 2022.A single low flow hazard alarm was captured on (b)(6) 2022, which lasted approximately 25 seconds.The observed low flow events also appeared to be associated with elevated pulsatility index (pi) values.No other notable events or alarms were captured, and the pump appeared to function as intended at the set speed.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 patient handbook, rev.D, are currently available.Section 1 of the ifu, "introduction", lists potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This section also addresses all pump parameters.Section 4 of the ifu, ¿system monitor¿, describes the pump flow display and the hazard alarms.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.Section 4 also explains that changes in patient condition can result in low flow.Section 6 of the ifu, "patient care and management" (under "ongoing patient assessment and care"), includes a list of heartmate 3 patient assessments, including assessment of the patient's level of consciousness.Section 5 of the patient handbook, ¿alarms and troubleshooting¿, and section 7 of the ifu, ¿alarms and troubleshooting¿, provides information on all system alarm conditions as well as the appropriate actions associated with each condition.A section on ¿handling emergencies¿ is also provided in the patient handbook.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 24jan2022.No further information was provided.The manufacturer is closing the file on this event.
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It was reported that the patient had a low flow alarm and passed out.The nurse had to shake the patient awake.The patient's blood pressure to 80 bpm.The nurse practitioner lowered the patient's speed from 5400 to 5300.The patient was given 500 mg intravenous fluids (ivf) and may have been dehydrated.Symptoms resolved, there were no further syncope episodes, and the patient's hydralazine was placed on hold.The plan of care was to increase ivf and monitor the patient.
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