Manufacturer's investigation conclusion the reported event of fluid ingress on the system controller was confirmed.Initial inspection of the returned heartmate 3 (hm3) system controller, serial (b)(6), revealed fluid ingress on the power cables and inside the controller.The controller was functionally tested and passed all steps without any issue.The controller operated on a mock circulatory loop for an extended period of time without reproducing any alarm.Despite the fluid ingress on the controller, the controller functioned as intended during analysis.A root cause of the reported event was not determined through this analysis.There were also an incidental finding of system controller power cable damage.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The patient handbook cautions the 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.Heartmate iii instructions for use (ifu) section 1 entitled ¿introduction¿ states that ¿if heartmate 3 patient are approved for showering, they must always use the shower bag.When installed properly, the shower bag protected external system components from water or moisture.If external system components have contact with water or moisture, the pump may stop¿.Heartmate iii patient handbook section 4 entitled ¿living with the heartmate 3¿ provides proper instruction on how to properly shower with the heartmate 3 system.Heartmate iii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including power cable disconnect.No further information was provided.The manufacturer is closing the file on this event.
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