BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC (CAC) ADAPTER

    MDR report key: 7935340 · Received October 4, 2018

    Report

    Report Number
    3007042319-2018-04665
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    August 22, 2014
    Report Date
    October 4, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. 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 THE DEVICE REVEALED THAT THE UNIT PASSED VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED AN OPEN INPUT FUSE. THE OPEN FUSE PREVENTED THE CAC ADAPTER FROM PROVIDING POWER, CONFIRMING THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO AN OPEN FUSE, DUE TO A COMBINATION OF A REDUCED FUSE IN-RUSH CURRENT RATING ALONG WITH THE ABSENCE OF A CURRENT-LIMITING THERMISTOR. AN INTERNAL INVESTIGATION WAS EVALUATED OPEN FUSES ASSOCIATED WITH CAC ADAPTERS. 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 AC (CAC) ADAPTER STOPPED POWERING THE CONTROLLER. THE CONTROLLER WOULD NOT RECOGNIZE THE CAC ADAPTER WHEN IT WAS CONNECTED AND THE GREEN LIGHT ON THE FRONT OF THE CAC ADAPTER WAS BLANK. THE CAC ADAPTER WAS EXCHANGED, 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
    777782 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC (CAC) ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1430DE CAC003532

    Patients

    Seq Age Sex Outcome Treatment
    1