BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER

    MDR report key: 8731378 · Received June 25, 2019

    Report

    Report Number
    3007042319-2019-07453
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 31, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE CONTROLLER AC (CAC) ADAPTER WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF CAC ADAPTER REVEALED THAT THE UNIT PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED A DAMAGED CABLE AND EXPOSED INTERNAL WIRES OF THE AC ADAPTER. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE AC ADAPTER CABLE BEING KINKED AS DESCRIBED IN THE EVENT DESCRIPTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROLLER ALTERNATING CURRENT (CAC) ADAPTER HAD A DAMAGED CABLE. IT WAS STATED THAT WHILE IN THE HOSPITAL, THE PATIENT WAS CHANGING THE POSITION OF THE BED AND THE CABLE GOT KINKED ON THE MOVING PORTION OF THE BED. THE CAC ADAPTER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524847 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1430DE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 1104 VAD