BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3910384 · Received July 2, 2014

    Report

    Report Number
    3007042319-2014-00684
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    January 22, 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

    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 TWO REPORTS (3007042319-2014-00683 AND 3007042319-2014-00684) 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.

    Additional Manufacturer Narrative · 1

    SIX 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. REVIEW AND ANALYSIS OF THE CONTROLLER LOG FILES CONFIRM THE REPORTED EVENT WHICH REVEALED A CONTROLLER POWER-UP AND MOTOR START EVENT ON THE REPORTED EVENT DATE, INDICATING THAT THE PATIENT EXPERIENCED A LOSS OF POWER. THE CONTROLLER LOGS ALSO REVEALED A CRITICAL BATTERY ALARM APPROXIMATELY 20 DAYS PRIOR TO THE REPORTED EVENT DATE. (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING; THE BATTERIES PERFORMED PER SPECIFICATION. FUNCTIONAL TESTING 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. THIS IS ONE OF THREE REPORTS (3007042319-2014-00158, 3007042319-2014-00683 AND 3007042319-2014-00684) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    FOUR MONTHS AFTER HVAD IMPLANTATION THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED AND A PUMP STOP. 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
    387773 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