Manufacturer's investigation conclusion: the reported low flow alarms were confirmed via the submitted log file data.According to the account, the low flows were due to hypertension and gastrointestinal bleeding.A direct correlation between heartmate 3 left ventricular assist system, serial number (b)(6), and the reported hypertension / gastrointestinal bleeding could not conclusively be determined.Controller event log file 20211109_034552 contained data on (b)(6) 2021 spanning from 09:30:56 to 16:20:08, per the timestamp.Numerous low flow events were captured throughout the log file when the estimated pump flow was calculated to be below the threshold of 2.5 liters per minute (lpm).A total of 28 low flow events persisted for at least 10 seconds, activating low flow alarms.No other notable alarms were captured.The controller event log file contained data spanning from (b)(6) 2021 at 14:42:19 to (b)(6) 2021 at 10:17:30, per the timestamp.Intermittent low flow events were captured on (b)(6) 2021 and (b)(6) 2021 when the estimated pump flow was calculated to be below the threshold of 2.5lpm.A total of 3 low flow events persisted for at least 10 seconds, activating low flow alarms.No other notable alarms were captured.The controller event log files appeared to have captured the pump operating as intended.The patient was seen in the clinic due to low flow alarms.The patient has reportedly had ongoing low flow alarms since being discharged from their ventricular assist device (vad) implant procedure.The patient¿s mean arterial pressure (map) was noted to be 88 millimeters of mercury (mmhg) in the clinic and the patient was started on hydralazine.The account later communicated that the cause of the low flow alarms was due to hypertension and gastrointestinal bleeding, and the alarms resolved with better map control.The patient underwent a capsule study and a push enteroscopy, which did not reveal any active lesions/bleeding.The patient¿s anticoagulation regimen has since been resumed and an outpatient colonoscopy procedure was to be performed.The patient remains ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system instructions for use, rev.C, contains the following information: section 1 lists bleeding and hypertension as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Speed, power, flow, and pulsatility are also outlined in this section.Section 4 describes the pump flow display and the hazard alarms.This section also states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow.Section 6 provides information regarding the recommended anticoagulation therapy and international normalized ratio range.Is also included in this section.Section 7 describes the actions to take in the event of a low flow alarm.No further information was provided.The manufacturer is closing the file on this event.
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