BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2961208 · Received February 14, 2013

    Report

    Report Number
    3007042319-2013-00024
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 15, 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 HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. THIS IS TWO OF TWO REPORTS, 3007042319-2013-00015 AND 3007042319-2013-00024.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE CONTROLLER LOG FILES FOR (B)(4) CONFIRMED THE EVENTS AS REPORTED. BOTH CONTROLLERS WERE RETURNED TO HEARTWARE AND PERFORMED AS INTENDED DURING FUNCTION TESTING. THIS IS ONE OF TWO REPORTS, 3007042319-2013-00015 AND 3007042319-2013-00024.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A BIVAD PATIENT WHO EXPERIENCED A VAD STOP CONDITION WITH THEIR CONTROLLER APPROXIMATELY THIRTEEN MONTHS POST HEARTWARE VAD IMPLANTATION. THE PATIENT'S CONTROLLER DEMONSTRATED LOW ESTIMATED FLOWS AND HIGH POWER CONSUMPTION. THE PRIMARY CONTROLLER WAS EXCHANGED WITH THE BACK-UP CONTROLLER. HOWEVER, THIS BACK-UP CONTROLLER DID NOT RE-START THE PUMP. THE HOSPITAL REPLACED BOTH OF THE PATIENT'S CONTROLLERS FROM THEIR STOCK AND THE PUMP WAS THEN RE-STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65730 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1