BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    MDR report key: 7529326 · Received May 21, 2018

    Report

    Report Number
    3007042319-2018-02016
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    April 26, 2018
    Report Date
    October 5, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE SHOULDER PACK, LOT 142153, 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 REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING AND VISUAL INSPECTION. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SHOULDER BAG, INCLUDING THE POCKET CONTROLLER, WAS GETTING EXTREMELY HOT. THE SITE ALSO REPORTED THAT THE PATIENT OFTEN LEAVES THEIR SHOULDER BAG UNZIPPED TO ALLOW HEAT TO DISSIPATE. THE ALLEGED DEVICE HAS BEEN EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373000 HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 2060US 142153

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 1103-VAD