BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 12508368 · Received September 21, 2021

    Report

    Report Number
    2916596-2021-05413
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 28, 2021
    Report Date
    September 21, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED BECAUSE THE PATIENT WAS ALARMING 'CONNECT DRIVELINE' WITHOUT ANY RESOLUTION. THE EMERGENCY MEDICAL TECHNICIAN WAS ON THE PHONE WITH THE PATIENT'S VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR AND THE PATIENT'S SYSTEM CONTROLLER CONTINUED TO ALARM 'CONNECT DRIVELINE'. THEY WERE ABLE TO CONFIRM THAT IT WAS AT THE MODULAR CABLE CONNECTION. THE VAD COORDINATOR WALKED THE EMT THROUGH HOW TO ENGAGE THE MODULAR CABLE CONNECTOR NUT, BUT THEY SAID THAT WHEN THEY HAD IT SECURED IT 'KEPT POPPING OFF'. IT WAS RECOMMENDED THAT THEY TAPE THE MODULAR CABLE TO THE PUMP CABLE UNTIL THE PATIENT COULD BE TRANSPORTED TO AN IMPLANT CENTER FOR EVALUATION, WHICH WAS DONE. THE PATIENT WAS ALERT THROUGHOUT THIS PROCESS. ADDITIONALLY, WHEN PLACED ON BATTERIES THE PATIENT HAD A 'CONNECT POWER' ALARM, AND THE PATIENT WAS THEREFORE STUCK USING THE MOBILE POWER UNIT (MPU). THE BATTERIES WERE CONFIRMED TO HAVE 2019 MANUFACTURE DATES. THEY ATTEMPTED TO TRY DIFFERENT BATTERIES AND CLIPS BUT WERE UNSUCCESSFUL. THE VAD COORDINATOR RELAYED THAT IT WAS URGENT FOR THE PATIENT TO BE BROUGHT TO THE HOSPITAL IMMEDIATELY, BUT THE PATIENT REFUSED. IT WAS THEN RECOMMENDED THAT AS A LAST RESORT THE CONTROLLER SHOULD BE EXCHANGED, SINCE THAT WAS THE ONLY COMPONENT ASIDE FROM THE MODULAR CABLE THAT HAD NOT BEEN TROUBLESHOT, HOWEVER, THE PATIENT HAD NO ADDITIONAL CONTROLLERS OR BACKUP EQUIPMENT ON THEM. THE VAD COORDINATOR AGAIN EMPHASIZED THE URGENCY OF COMING TO THE HOSPITAL, BUT THE PATIENT CONTINUED TO REFUSE TRANSPORT TO THE EMERGENCY DEPARTMENT (ED) AND STATED THAT THEIR DAUGHTER WOULD BE CALLED TO PROVIDE SUPPORT. RELATED MANUFACTURER'S REFERENCE NUMBER FOR THE MODULAR CABLE AND SYSTEM CONTROLLER: 2916596-2021-05407, 2916596-2021-05414.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403578 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525US 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR