BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4073019 · Received September 9, 2014

    Report

    Report Number
    3007042319-2014-00937
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 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
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE AVAILABLE FOR EVALUATION, BUT HAVE NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    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. (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING; THE DEVICES PERFORMED PER SPECIFICATION. HOWEVER, LOG FILE ANALYSIS CONFIRMED THE OCCURRENCE OF PREMATURE BATTERY SWITCHING AND CRITICAL BATTERY ALARMS WHICH CORRELATES TO THE REPORTED EVENT. IT HAS BEEN DEMONSTRATED THAT THIS ISSUE IS MOST LIKELY RELATED TO A FAULTY INTERNAL CELL PAIR OR A COMMUNICATION ISSUE BETWEEN THE CONTROLLER AND THE CONNECTED BATTERY CURRENTLY BEING INVESTIGATED. ADDITIONALLY, FUNCTIONAL ANALYSIS REVEALED THAT (B)(4) CONTAINED A FAULTY 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

    THIS EVENT INVOLVED A PATIENT ONE YEAR AND 8 MONTHS POST HEARTWARE LVAD IMPLANTATION WHO REPORTS THAT HER CONTROLLER WENT BLANK DURING A BATTERY EXCHANGE. THE PATIENT WAS REPORTED TO BE REMOVING A BATTERY BECAUSE THE CONTROLLER WAS SWITCHING BETWEEN POWER SOURCES. THE PATIENT WAS ASYMPTOMATIC AND THE CONTROLLER "RESTARTED" WHEN AC POWER WAS APPLIED. IN ADDITION TO POWER SWITCHING, THE PATIENT ALSO REPORTED UNUSUAL BEHAVIOR OF CHARGE CAPACITY INDICATORS AND LOW BATTERY ALARMS WHEN THE BATTERY WAS NOT DEPLETED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553732 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

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