BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 9244353 · Received October 28, 2019

    Report

    Report Number
    3007042319-2019-12286
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    January 2, 2019
    Report Date
    October 28, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. THE BATTERY 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 THE RETURNED DEVICE REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT THE BATTERY WAS RECEIVED INOPERABLE. THE BATTERY WAS RECEIVED WITH A PACK UNDER VOLTAGE (PUV) AND CELL UNDER VOLTAGE (CUV) FLAG ENABLED AS WELL AS PERMANENT FLAGS ENABLED. A CELL-UNDER-VOLTAGE FLAG IS TRIGGERED WHEN A CELL PAIR FALLS BELOW A VOLTAGE THRESHOLD. LIKEWISE, A PACK-UNDER-VOLTAGE FLAG IS TRIGGERED WHEN THE BATTERY PACK FALLS BELOW A VOLTAGE THRESHOLD. CHARGING THE BATTERY WILL CLEAR THE PUV AND CUV FLAG. SUPPLEMENTAL TESTING REVEALED THERE WAS A COMMUNICATION ERROR BETWEEN THE GAS GAUGE INTEGRATED CHIP (IC) THAT MONITORS THE BATTERY AND REPORTS INFORMATION TO THE CONTROLLER AND THE IC THAT MEASURES CELL PAIR VOLTAGES AND PROVIDES SAFETY PROTECTION WHEN CERTAIN CONDITIONS ARE MET. THIS COMMUNICATION ERROR CAUSED THE BATTERY TO TRIGGER THE FLAGS AND BECOME INOPERABLE. THE BATTERY REGAINED FUNCTIONALITY AFTER REMOVING THE BATTERY PACK FROM THE CIRCUIT, CHARGING IT, AND RECONNECTING IT AGAIN TO THE CIRCUIT. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE BATTERY NOT ABLE TO CHARGE OR PROVIDE POWER MAY BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE GAS GAUGE INTEGRATED CIRCUIT (IC) AND THE FRONT-END CIRCUIT. INTERNAL EVALUATION INVESTIGATED BATTERY MAIN INTEGRATED CIRCUIT MALFUNCTIONS. 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. THE BATTERY 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
    1039015 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650DE 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR