BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3759374 · Received April 18, 2014

    Report

    Report Number
    3007042319-2014-00348
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 19, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Description of Event or Problem · 1

    APPROXIMATELY TWO WEEKS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT CAC ADAPTER DOES NOT STAY SECURELY CONNECTED TO THE CONTROLLER. PRELIMINARY LOG FILE REVIEW CONFIRMED A PUMP STOP. THE CAC ADAPTER WAS TAKEN OUT OF SERVICE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238306 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CAC ADAPTER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1