BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3945617 · Received July 21, 2014

    Report

    Report Number
    3007042319-2014-00755
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    September 26, 2013
    Report Date
    June 19, 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
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVALUATION AND TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER OUR SOP REQUIREMENTS, AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S DEVICES WERE EXCHANGED WITHOUT INCIDENT AND THERE WAS NO REPORTED PATIENT INJURY. A BATTERY CHARGER, CONTROLLER AC ADAPTER, TWO CONTROLLERS, AND BATTERIES WERE RETURNED TO HEARTWARE FOR EVALUATION; THE DEVICES ARE RELATED TO THE REPORTED EVENT. RECORDS INDICATE THAT THE UNIT MET THE INTERNAL REQUIREMENTS PRIOR TO ITS QUALITY ASSURANCE RELEASE PROCESS. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THE BATTERY CHARGER, CONTROLLER AC ADAPTER, TWO CONTROLLERS, AND THREE BATTERIES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING; THE ANALYZED DEVICES PERFORMED PER SPECIFICATION UNDER TESTING CONDITIONS AND WERE UNABLE TO DUPLICATE THE REPORTED EVENT AT BENCH LEVEL. FUNCTIONAL ANALYSIS REVEALED THAT (B)(4) CONTAINED A FAULTY INTERNAL CELL PAIR WHICH MOST LIKELY CONTRIBUTED TO THE REPORTED EVENT. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PERFORMANCE OF THE BATTERY. THE BATTERY WAS REMOVED FROM THE PATIENT AND A NEW BATTERY WAS SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424746 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

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