BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 4776114 · Received May 15, 2015

    Report

    Report Number
    3007042319-2015-00880
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 16, 2015
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS AND ASSOCIATED CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS IS ONE OF SIX REPORTS (3007042319-2015-0000876,3007042319-2015-0000877,3007042319-2015-0000878,3007042319-2015-0000879,3007042319-2015-0000880 AND 3007042319-2015-0000881,) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. BATTERIES HAVE NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    BASED ON THE RESULTS OF THE PREVIOUS MANUFACTURER'S INTERNAL INVESTIGATION, FIELD ACTIONS AND CHANGES TO THE BATTERY INTERNAL CELL SUPPLIER, NO ADDITIONAL INVESTIGATION OF THIS EVENT IS REQUIRED AT THIS TIME. THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO FAULTY INTERNAL CELLS WITHIN THE BATTERY PACK. THIS IS ONE OF SIX REPORTS (3007042319-2015-0000876,3007042319-2015-0000877,3007042319-2015-0000878,3007042319-2015-0000879,3007042319-2015-0000880 AND 3007042319-2015-0000881,) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR STATES THAT "ALL SIX BATTERIES SWITCH BACK AND FORTH BEFORE DEPLETING CHARGE." THIS IS REPORT 5 OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320111 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1