BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6899612 · Received September 27, 2017

    Report

    Report Number
    3007042319-2017-03409
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    February 11, 2016
    Report Date
    February 19, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    UDI-DI
    00888707000093
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 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. THE REPORTED EVENT WAS CONFIRMED VIA FUNCTIONAL TESTING. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION BUT FAILED FUNCTIONAL TESTING DUE TO A VARIABLE OUTPUT VOLTAGE. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. AN INTERMITTENT LACK OF CONTINUITY WITHIN THE CAC ADAPTER'S CABLE CAN CAUSE A CONTROLLER TO SWITCH TO BATTERY POWER. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A LACK OF CONTINUITY IN THE CAC ADAPTER'S GROUND WIRE. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS, WHICH WAS IN RESPONSE TO AN UPDATE TO THE MDR DECISION CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD EQUIPMENT MANAGER THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2016 AND REPORTED THAT CAC- ADAPTER WAS ONLY SUPPLYING INTERMITTENT POWER. HE REPORTED THAT THE ADAPTER WAS SECURELY CONNECTED TO CONTROLLER AND WALL OUTLET, BUT THAT IT WOULD INTERMITTENTLY SWITCH TO BATTERY POWER WHEN CONNECTED. THE CAC WAS REPLACED AND TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678453 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC 00888707000093

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR