BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3910586 · Received July 2, 2014

    Report

    Report Number
    3007042319-2014-00687
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    February 4, 2014
    Report Date
    June 3, 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

    THE BATTERIES WERE EXCHANGED WITHOUT INCIDENT AND RETURNED TO HEARTWARE; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE BATTERIES 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 DEVICE PERFORMED PER SPECIFICATION. (B)(4) FAILED FUNCTIONAL TESTING DUE TO A PERMANENT FAILURE FLAG, RENDERING THE BATTERY INOPERABLE. ADDITIONALLY, FUNCTIONAL ANALYSIS REVEALED THAT (B)(4), (B)(4), AND (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 THIS IS ONE OF FIVE REPORTS (3007042319-2014-00157, 3007042319-2014-00685, 3007042319-2014-00686, 3007042319-2014-00687, AND 3007042319-2014-00688) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    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 FIVE REPORTS (3007042319-2014-00157, 3007042319-2014-00685, 3007042319-2014-00686, 3007042319-2014-00687, AND 3007042319-2014-00688) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. THIS EVENT RELATES TO THE FSCA Z-1607-2014 ISSUED BY HEARTWARE, INC. FOR THIS MATTER. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    ONE YEAR AND SEVEN MONTHS AFTER HVAD IMPLANTATION THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED AND A POWER LOSS. PRELIMINARY LOGS FILES REVIEW CONFIRMED THE PUMP STOP. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387662 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