Manufacturer's investigation conclusion: the reported event of the rubber casing on the patient cable being loose around the black and white lemo connectors was confirmed.The returned mobile power unit (mpu), serial number (b)(6), was evaluated at the european distribution center (edc) and reported event was confirmed via visual inspection of the returned unit.The mpu was functionally tested and found to function as intended during analysis.The patient cable was replaced.A full functional checkout was performed and the unit passed all tests.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(6) was shipped to the customer on 29jun2015.Heartmate 3 instructions for use (rev.G) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.G) section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the mobile power unit (mpu).Heartmate 3 patient handbook (rev.G) and section 10 and heartmate 3 instructions for use (rev.G) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the mpu patient cable for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook (rev.G) 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.No further information was provided.The manufacturer is closing the file on this event.
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