BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4201080 · Received October 27, 2014

    Report

    Report Number
    3007042319-2014-01123
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 26, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE PUMP REMAINS IMPLANTED. TWO BATTERIES WERE EXCHANGED AND RETURNED TO HEARTWARE FOR EVALUATION. THE BATTERIES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING; THE DEVICES PERFORMED PER SPECIFICATION. THE REPORTED EVENT WAS CONFIRMED VIA LOG ANALYSIS WHICH REVEALED ONE OCCURRENCE OF BATTERY SWITCHING AND TWO CRITICAL BATTERY ALARMS. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, CONTROLLER LOG FILE ANALYSIS INDICATES A POTENTIAL COMMUNICATION ANOMALY BETWEEN THE CONTROLLER AND THE CONNECTED BATTERY.

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. HOWEVER, THE BATTERIES ((B)(4)) HAVE BEEN RECEIVED BY THE MANUFACTURER FOR FURTHER EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH-IN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    APPROXIMATELY EIGHT MONTHS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED POWER SWITCHING FROM ONE PORT OF THE CONTROLLER TO THE OTHER. ALL THE BATTERIES WERE REPLACED AND RETURNED TO HEARTWARE FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT; THE ISSUE WAS RESOLVED WITH THE REPLACEMENT BATTERIES. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682050 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - BATTERY| (B)(4) - BATTERY