Manufacturer's investigation conclusion.The reported event of damaged power cables on the system controller was confirmed via the returned system controller.The heartmate 3 system controller (serial number (b)(4)) was returned for analysis.The system controller was visually inspected, and cuts were found on both power cables as well as broken strain reliefs on both power cables, confirming the reported event.The controller was connected to a test system monitor, power module, and pump and operated as intended.The controller was then operated on battery power and operated as intended.The returned controller was then functionally tested and did not pass due to elevated resistances in the underlying wires on both power cables.The system controller power cables were replaced with known working cables and the controller was re-submitted for functional testing and the controller passed all steps without issue.The root cause of the reported event could not be determined through this analysis.During the investigation there were incidental findings of underlying wire fatigue in both power cables, fluid ingress in both power cables, and discolored user interface of the controller.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial#: (b)(4)) was manufactured in accordance with manufacturing and quality assurance specifications.(b)(4) was shipped to the customer on (b)(6) 2019.Heartmate iii patient handbook, under section 5 ¿alarms and troubleshooting¿ and heartmate iii instructions for use (ifu), under section 7, subsection ¿what not to do: driveline and cables¿ informs the user to check the system controller power cables for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to ¿twist, kink, or sharply bend the system controller power cables¿ and states ¿if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.Heartmate iii patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the system controller power cables.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate iii lvad, including inspecting the system controller and power cables for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate iii instructions for use (ifu) under section 2 entitled ¿system operations¿ informs the user to ¿keep the system controller power cables dry and away from water or liquid¿ as it may cause the system to fail or serious electric shock.Section 7 entitled ¿frequently asked questions¿ explains the potential hazards and informs the user to call their hospital contact if the system controller gets wet or is dropped.Heartmate iii patient handbook and heartmate iii instructions for use (ifu) caution 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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