It was reported by the vad coordinator that the patient had flows that steadily stayed around the 2.5lpm threshold.This caused persistent low flow alarms.It was reported that the low flow alarms were due to severe right ventricular (rv) dysfunction, the software on the system controllers were updated however, the patient continues to have intermittent low flow alarms.
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Manufacturer¿s investigation conclusion: the report of low flow alarms can be confirmed based on the onsite evaluation by an abbott representative.A direct correlation between the device and the reported right heart failure could not be conclusively determined through this evaluation.The customer requested a low flow software upgrade to reduce the patient¿s low flow limit from 2.5lpm to 2.0lpm due to persistent low flow alarms.The upgrade was completed on (b)(6) 2020 with no issues.New software labels were added to the controllers, and the patient and clinical staff were given copies of the low flow alarm guides.Multiple attempts were made to obtain additional information, but no response was recorded.Upon review of the patient¿s complaint history, no other related complaints were noted.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).The heartmate 3 lvas instructions for use (ifu) lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.The heartmate 3 lvas ifu describes the pump flow display and the hazard alarms.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.The heartmate 3 lvas patient handbook describes the actions to take in the event of a low flow alarm.A review of the device history records found no deviations from manufacturing specifications.No further information was provided.The manufacturer is closing the file on this event.
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