Related manufacturer report number: 2916596-2022-11999.It was reported that pump-priming was aborted.During the pump startup, the pump power increased to 2.4 and then to 2.8, but the pump did not start within 10 seconds.Pump speed was 0 rpm.The pump was stopped and the connections were rechecked by disconnecting and reconnecting.Then the tech restarted the pump via the start button on the monitor.The pump power was increasing again to 2.0 - 2.3 then after about 6 seconds the pump started and the speed showed 3,000 rpm.Pump power continued to increase to 2.8.The pump was stopped and the connections and the position of the pump within the ns container were rechecked.This time when the pump was started the pump started normally but the pump power increased to 2.1 - 2.2.It was noted that the inflow cannula was against the wall of the container.Once it was moved, the power came back down to 1.5 - 1.8.The fourth time the pump was started, it started normally, pump power was at 1.4-1.6.The decision was made to not use the pump and a new heartmate 3 left ventricular assist device (lvad) kit was used.
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Upon further review of the reported events, heartmate 3 system controller serial number (b)(6) does not meet regulatory reporting criteria.Manufacturer's investigation conclusion: the reported event of the system not starting properly was confirmed via the log file which was extracted from the returned system controller during testing (serial number (b)(6); however, the cause of the issue was determined to be unrelated to the controller.The clock was not set throughout the data, appearing as the default timestamp of 01jan2000.The pump was observed to ramp up to 3000 rpm four times throughout the data, consistent with the reported event.Only the white power cable of the controller was connected to power during the first attempts to start the pump.The current draw from the pump during start up caused the measured voltage in the white power cable to decrease to at least 9v, resulting in a low power hazard.The system is designed to prevent the pump from attempting to start if the system controller is not connected to external power.This decrease in voltage appeared to cause the intentional pump stop flag to re-enable 3 seconds later per the recorded timestamp.This sequence of events repeated on the second attempt to start the pump.The driveline was then disconnected less than 30 seconds later, and the black power cable was connected to the power module patient cable.The driveline was then reconnected and the pump start button was pressed again.The pump started within 4 seconds.The pump was stopped and restarted two additional times before the end of the log file.The returned system controller was functionally tested and was found to perform as intended.Atypical events were unable to be reproduced throughout all testing.Due to the age and functional testing results of the controller in tandem with log file findings, the voltage drops observed within the log file will be addressed via the 14-volt patient cable¿s investigation.The heartmate 3 patient handbook section titled "emergency contact list", cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.
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