BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- CAC ADAPTER

    MDR report key: 7028282 · Received November 14, 2017

    Report

    Report Number
    3007042319-2017-03994
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 4, 2015
    Report Date
    November 14, 2017
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CAC WAS EVALUATED TO DETERMINE ITS RELATIONSHIP WITH THE REPORTED EVENT. THE DEVICE PASSED FUNCTIONAL INSPECTION. DEVICE PERFORMED AS PER SPECIFICATIONS. THE REPORTED EVENT COULD NOT BE DUPLICATED AT THE BENCH LEVEL. 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. 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 PATIENT UNDERWENT A CONTROLLER EXCHANGE AND IT WAS NOTED THAT THE PATIENT'S CAC ADAPTER WOULD NOT STAY CONNECTED TO THE NEW CONTROLLER. THE CAC ADAPTER WAS EXCHANGED WITH NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807554 HEARTWARE VENTRICULAR ASSIST SYSTEM- CAC ADAPTER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1425US

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR