BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 17825738 · Received September 27, 2023

    Report

    Report Number
    2916596-2023-07057
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 22, 2023
    Report Date
    December 13, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE SYSTEM CONTROLLER¿S GREEN PUMP LEDS BEING DIMMED WAS CONFIRMED. A LOG FILE WAS EXTRACTED FROM THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER (B)(6)) CONTAINING DATA SPANNING APPROXIMATELY 3 DAYS ((B)(6) 2023 PER TIMESTAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE, AND NO ATYPICAL EVENTS WERE OBSERVED. THE RETURNED SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED. UPON BEING CONNECTED TO A MOCK LOOP, THE GREEN LEDS THAT SIGNIFY WHETHER THE PUMP IS RUNNING WERE OBSERVED TO BE DIM; HOWEVER, THE CONTROLLER FUNCTIONED AND OPERATED A MOCK LOOP AS INTENDED THROUGHOUT ALL TESTING. ALTHOUGH THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED, THE ISSUE OF DIM GREEN PUMP LEDS ON THE SYSTEM CONTROLLER HAS BEEN ADDRESSED VIA A CORRECTIVE ACTION. THIS CONTROLLER WAS MANUFACTURED BEFORE THE CORRECTIVE ACTION WAS IMPLEMENTED. REVIEW OF THE DEVICE HISTORY RECORD FOR SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE (QA) SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK INSTRUCTS USERS TO NEVER SUBMERGE THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLER, UNDERWATER. THE PATIENT HANDBOOK ALSO INSTRUCTS USERS TO NEVER EXPOSE THEIR EQUIPMENT TO LIQUIDS OR FLUIDS OF ANY KIND. THE HEARTMATE 3 PATIENT HANDBOOK SECTION TITLED "CHECKLISTS¿ INSTRUCTS USERS TO REGULARLY INSPECT THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLERS, AND TO AVOID USING EQUIPMENT THAT APPEARS DAMAGED. USERS ARE ENCOURAGED TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED. THE HEARTMATE 3 PATIENT HANDBOOK SECTION TITLED "EMERGENCY CONTACT LIST") 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.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GREEN ARROW DIODES DID NOT LIGHT UP VISIBLY. THE CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442093 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106531INT 7151494

    Patients

    Seq Age Sex Outcome Treatment
    1 Male