BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3930094 · Received July 11, 2014

    Report

    Report Number
    3007042319-2014-00714
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    February 5, 2014
    Report Date
    June 11, 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

    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. THIS IS ONE OF FOUR REPORTS (3007042319-2014-00327, 3007042319-2014-00712, 3007042319-2014-00713, AND 3007042319-2014-00714) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE CONTROLLER AND BATTERIES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE BATTERY REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. FUNCTIONAL ANALYSIS REVEALED THAT THE BATTERY 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 IS ONE OF FOUR REPORTS (3007042319-2014-00327, -2014-00712, -2014-00713, AND -2014-00714) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND ELEVEN MONTHS POST IMPLANTATION, THE SITE REPORTED THAT THE PATIENT'S CONTROLLER WAS CHANGING POWER SOURCES EARLIER THAN EXPECTED. THE CONTROLLER AND BATTERIES WERE REMOVED FROM THE PATIENT AND A NEW CONTROLLER AND BATTERIES WERE SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. A PRELIMINARY REVIEW OF THE LOG FILES INDICATED THE PATIENT EXPERIENCED A PUMP STOP ON THE SAME DATE OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407549 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) - CONTROLLER| (B)(4) - BATTERY| (B)(4) - BATTERY