BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3983948 · Received August 6, 2014

    Report

    Report Number
    3007042319-2014-00805
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIX BATTERIES WERE RETURNED TO HEARTWARE FOR EVALUATION; THE DEVICES RELATED TO THE REPORTED EVENT WERE EXCHANGED WITHOUT INCIDENT AND THERE WAS NO REPORTED PATIENT INJURY. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING; THE DEVICES PERFORMED PER SPECIFICATION. REVIEW AND ANALYSIS OF THE CONTROLLER LOG FILES CONFIRM INAPPROPRIATE BATTERY SWITCHING CORRESPONDING TO THE REPORTED EVENT. IT HAS BEEN DEMONSTRATED THAT THE REPORTED POWER SWITCHING EVENTS WITH CRITICAL BATTERY ALARMS ARE INDICATIVE OF A COMMUNICATION ISSUE BETWEEN THE CONTROLLER AND THE CONNECTED BATTERY THAT MAY CONTRIBUTE TO THE REPORTED EVENT. FUNCTIONAL TESTING REVEALED THAT (B)(4) CONTAINED A FAULTY CELL PAIR WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT; FURTHER ANALYSIS REVEALED SOLDER ASSEMBLY ISSUES ON THE BATTERY'S CIRCUIT BOARD. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. THE BATTERIES WERE REMOVED FROM THE PATIENT AND A NEW SET WAS SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. A PRELIMINARY REVIEW OF THE CONTROLLER LOG FILES REVEALED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459566 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

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