Section d4: expiration date was inadvertently included in the initial report and is not applicable for this device manufacturer's investigation conclusion: the reported events of issues with the patient cable connector and damage on the battery compartment cover were confirmed via evaluation of the returned mobile power unit (mpu) (serial number: (b)(6)).The mpu was evaluated at european distribution center (edc) and manipulation of the patient cable rubber encasing revealed that it was loose due to a gap being observed between the plastic lemo connectors and the rubber.Further inspection revealed that the battery compartment cover was slightly cracked near the locking screw.The mpu was connected to a mock circulatory loop and operated without any issues observed or alarms active.The damage observed did not affect the functionality of the unit.The mpu was then functionally tested and the unit passed without any issues.The mpu was then returned to the rental pool.The root cause of the reported events could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the mobile power unit, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The mobile power unit was shipped to the customer on (b)(6) 2016.Heartmate 3 instructions for use (ifu) (rev.G) section 8, entitled ¿equipment storage and care¿, and heartmate 3 patient handbook (rev.G) section 6, entitled ¿caring for equipment¿, explain how to properly care for the equipment, including the mpu and the patient cable.Heartmate 3 patient handbook (rev.G) section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the mpu and the mpu patient cable connectors for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.The heartmate 3 patient handbook (rev.G) cautions the user 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.No further information was provided.The manufacturer is closing the file on this event.
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