BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3854336 · Received June 6, 2014

    Report

    Report Number
    3007042319-2014-00583
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    August 13, 2013
    Report Date
    May 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERIES WERE RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE BATTERIES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. FUNCTIONAL TESTING REVEALED THAT THE RETURNED BATTERIES CONTAINED A FAULTY CELL PAIR, WHICH MOST LIKELY CONTRIBUTED TO THE REPORTED EVENT. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE. THIS EVENT RELATES TO THE FSCA (B)(4) ISSUED BY HEARTWARE, INC. FOR THIS MATTER. THIS IS ONE OF TWO REPORTS (3007042319-2014-00582, AND 583) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY THREE MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT'S BATTERIES WERE NOT HOLDING CHARGE. THE BATTERIES WERE REMOVED FROM THE PATIENT AND NEW BATTERIES WERE 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
    332888 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BAT092882- BATTERY