Manufacturer's investigation conclusion: the report of low flow events was confirmed via the submitted log file.According to the account, the low flows were thought to be positional and/or related to a degree of recovery.Adequate fluid intake was encouraged.A direct correlation between (b)(6) and the reported event could not conclusively be determined.The submitted log file contained data from (b)(6) 2020.The pump speed remained above the low speed limit for the duration of the log file.Multiple low flow events were recorded throughout the file when the patient¿s calculated flow was captured below the low flow threshold of 2.5 lpm.The log file also captured pulsatility index (pi) events and routine power exchange events.There were no other notable events captured in the log file.The file appeared to show the pump operating as intended.On (b)(6) 2021, it was reported that the low flow alarms are ongoing and likely positional and/or related to a degree of recovery.Additionally, the plan of care for the patient was to continue with heart failure treatment and encourage adequate fluids.The patient was noted as stable with no changes.The patient is ongoing on heartmate ii left ventricular assist system serial number, (b)(6).The relevant sections of the device history records of (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 "introduction" of the ifu provides an explanation of all pump parameters, including pump flow.Section 4 provides more information regarding all pump parameters and also describes situations which may result in a low flow hazard alarm.Section 6 "patient care and management" explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions including the low flow hazard as well as the appropriate actions associated with them.No further information was provided.The manufacturer is closing the file on this event.
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