BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 2980791 · Received February 27, 2013

    Report

    Report Number
    3007042319-2013-00017
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 28, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4): PRODUCT IS IN ROUTE.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR FURTHER ANALYSIS. THE REPORTED EVENT WAS CONFIRMED THROUGH A REVIEW OF THE LOG FILES WHICH RECORDED A "CONTROLLER FAULT" ALARM. A REVIEW OF THE NON-CONFORMING MATERIAL RECORD (NCMR) LOG INDICATES THAT THE CONTROLLER IN QUESTION HAD NO NON-CONFORMING ISSUES DURING PROCESSING AND FUNCTIONED APPROPRIATELY PRIOR TO RELEASE. WITHOUT THE RETURN OF THE COMPLAINT DEVICE, THE ROOT CAUSE FOR THE CONTROLLER FAULT CANNOT BE CONCLUSIVELY DETERMINED. (B)(4): PRODUCT NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED A CONTROLLER FAILURE ALARM APPROXIMATELY THREE YEARS POST HEARTWARE® LVAD IMPLANTATION. THE PATIENT REPORTED GETTING A RED CONTROLLER (B)(4) ALARM WHILE CHANGING FROM CARRYING CASE TO THEIR NEW WAIST PACK. THE PATIENT CALLED THE HOSPITAL AND WAS ADVISED TO PERFORM A CONTROLLER EXCHANGE. THE EXCHANGE WAS PERFORMED WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85016 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1