BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 10534840 · Received September 15, 2020

    Report

    Report Number
    2916596-2020-04570
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    September 8, 2020
    Report Date
    December 1, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A CUT IN THE MODULAR CABLE WAS CONFIRMED. THE MODULAR CABLE WAS RETURNED WITH A CUT THROUGH THE PROTECTIVE LAYERS, WITH SEVERAL SEVERED WIRES. THE RETURNED MODULAR CABLE WAS CONNECTED TO A TEST SYSTEM CONTROLLER, A HM3 TEST PUMP, PATIENT CABLE, POWER MODULE, AND SYSTEM MONITOR. THE SYSTEM OPERATED AS INTENDED BUT INDICATED COMMUNICATION AND DRIVELINE POWER FAULTS ON THE SYSTEM MONITOR. MANIPULATING THE CABLE CAUSED THE PUMP TO CEASE OPERATION; THE SYSTEM MONITOR INDICATED PUMP OFF, DRIVELINE DISCONNECTED, AND LOW FLOW ALARMS, AND SHOWED FUSE B AS FAILED. THE MODULAR CABLE WIRES WERE TESTED FOR CONDUCTOR BREAKDOWN ALONG WITH INSULATION TESTING, AND FAILED TESTING. THE CABLE JACKET IN THE VICINITY OF THE MODULAR CABLE DAMAGE WAS REMOVED, AND IT WAS FOUND THAT THE BLACK, BROWN, RED, YELLOW, AND GREEN WIRES WERE ALL CUT THROUGH, AND THE ORANGE WIRE WAS DAMAGED BUT STILL CONNECTED BY A FEW STRANDS. THE ROOT CAUSE OF THE PUMP STOP EVENT WAS CONCLUSIVELY DETERMINED TO BE A CUT IN THE WIRES OF THE MODULAR CABLE. THE ROOT CAUSE OF THE CUT IN THE MODULAR CABLE WAS CONCLUSIVELY DETERMINED TO BE USER ERROR BY CUTTING WIRES IN THE DRIVELINE MODULAR CABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED (LOT # 7112757) AND THE RECORDS REVEALED THAT THE HEARTMATE III MODULAR CABLE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ENTITLED ¿EQUIPMENT MAINTENANCE¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. THE PATIENT HANDBOOK ALSO CAUTIONS THE 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 · 1

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

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2020-04569. IT WAS REPORTED THAT THE DEVICE HAD A CUT ON THE DRIVE CABLE. THE PUMP WAS OFF AND COMMUNICATION BETWEEN PUMP AND CONTROLLER WAS FAULT. THE PATIENT WAS CLOSER TO THE CENTER IN (B)(6), SO IT WAS ASKED TO ARRANGE AIR TRANSPORT THERE. THE PATIENT APPEARED IN GOOD GENERAL CONDITION. THE DRIVELINE AND THE CONTROLLER WERE REPLACED, THE FUSES IN THE DAMAGED ONE WERE OPENED AND UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998984 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525INT 7112757

    Patients

    Seq Age Sex Outcome Treatment
    1 HEARTMATE 3 SYSTEM CONTROLLER| HEARTMATE 3 SYSTEM CONTROLLER