BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 7072956 · Received November 30, 2017

    Report

    Report Number
    3007042319-2017-04403
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    August 14, 2017
    Report Date
    February 12, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FINAL PRODUCT EVENT SUMMARY: VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION. FUNCTIONAL TESTING REVEALED A CELL-UNDER-VOLTAGE AND PACK-UNDER-VOLTAGE FLAG, WHICH RENDERED THE BATTERY INOPERABLE. A CELL-UNDER-VOLTAGE FLAG IS TRIGGERED WHEN A CELL PAIR FALLS BELOW A VOLTAGE THRESHOLD. SIMILARLY, A PACK-UNDER-VOLTAGE FLAG OCCURS WHEN THE BATTERY PACK FALLS BELOW THE VOLTAGE THRESHOLD. INTERNAL INSPECTION OF THE BATTERY REVEALED A LIFTED CELL WELD, WHICH CONTRIBUTED TO THE UNDER-VOLTAGE FLAGS. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A LIFTED CELL WELD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE REPORTED EVENT OF "BATTERY CAN NOT BE CHARGED IN THE CHARGER, DOES NOT MATTER IN WHICH SLOT" IS CONFIRMED AT BENCH TESTING. BATTERY WAS OPENED UP AND TOTAL VOLTAGE WAS BELOW 10 VOLTS. THIS COULD BE SEEN ON TI AS AN CUV, PUV FLAG. ALSO CELL #3 WAS 0 VOLTS. AFTER EXAMINING THE WELDING ON THE PTC WAS LOOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS NOT CHARGING DESPITE ATTEMPTING TO CHARGE IN MULTIPLE SLOTS ON THE BATTERY CHARGER. THE BATTERY WAS EXCHANGED. THE BATTERY WAS RETURNED TO THE MANUFACTURER AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850458 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 1104 VAD