BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER

    MDR report key: 7453003 · Received April 23, 2018

    Report

    Report Number
    3007042319-2018-01562
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    March 29, 2018
    Report Date
    September 13, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002738
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH 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 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 RETURNED DEVICE REVEALED THAT THE CONTROLLER AC ADAPTER PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE CONTROLLER AC ADAPTER WAS ABLE TO ADEQUATELY PROVIDE POWER TO A TEST CONTROLLER. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A MARGINAL CONNECTION BETWEEN THE CONTROLLER AC ADAPTER AND THE ELECTRICAL OUTLET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OPERATIVE, THE CONTROLLER AC (CAC) ADAPTER DID NOT PROVIDE POWER. THE CAC ADAPTER WAS CONNECTED TO THE CONTROLLER, BUT NO GREEN LIGHT WAS SEEN. CONNECTIONS WERE CHECKED AND A DIFFERENT OUTLET WAS TRIED, BUT NO POWER WAS SUPPLIED BY THE CAC ADAPTER. THE CAC ADAPTER WILL BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE CAC ADAPTER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293390 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1430US 00888707002738

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR