Manufacturer's investigation conclusion: the reported damage to the system controller black power cable was not confirmed.The heartmate 3 system controller (serial number (b)(6)) was not returned for analysis.In addition, there were no photos, or supporting documentation submitted that would indicate an issue with the system controller.Emails with requests for missing meaningful data and/or event details were sent to customer, asking if the system controller will be returning for further analysis.Per customer response , the controller will not be returning for evaluation.As a result, the root cause of the reported damage was unable to be determined in this analysis.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial#: (b)(6)) was manufactured in accordance with manufacturing and quality assurance specifications.Heartmate iii patient handbook, under section ¿alarms and troubleshooting¿ and heartmate iii instructions for use (ifu) under section , 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 "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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