BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3910231 · Received July 2, 2014

    Report

    Report Number
    3007042319-2014-00682
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    January 16, 2014
    Report Date
    June 2, 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 EVENT RELATES TO THE FSCA Z-1607-2014 ISSUED BY HEARTWARE, INC. FOR THIS MATTER. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE CONTROLLER AND BATTERIES WERE 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 CONTROLLER AND BATTERIES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. THE CONTROLLER AND FOUR BATTERIES PASSED FUNCTIONAL TESTING, HOWEVER, 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

    APPROXIMATELY ONE YEAR AND FOUR MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. 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
    386531 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)- CONTROLLER| (B)(4)- BATTERY