BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOWER BAG

    MDR report key: 7965043 · Received October 15, 2018

    Report

    Report Number
    3007042319-2018-04816
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 18, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SHOWER BAG (LOT NO:893643) WAS NOT RETURNED FOR EVALUATION. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS INVOLVING A DAMAGED SHOWER BAG CAN BE ATTRIBUTED, TO THE HANDLING OF THE BAG AS REPORTED IN THE EVENT DETAILS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) SHOWER BAG WAS CUT AFTER BEING WASHED IN THE WASHING MACHINE. THE BAG WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808068 HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOWER BAG VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 2000IT 893643

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 1103 VAD| 1103 VAD