BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3854441 · Received June 6, 2014

    Report

    Report Number
    3007042319-2014-00591
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 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

    THE DEVICES WERE EXCHANGED WITHOUT INCIDENT AND THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE NOT RETURNED TO HEARTWARE FOR ANALYSIS AND TESTING; THEREFORE THE CAUSE OF THIS REPORTED EVENT CANNOT BE DETERMINED. ABNORMAL BATTERY BEHAVIOR IS A KNOWN ISSUE; WHILE THE CAUSES ARE MULTIFACTORIAL, IT HAS BEEN DEMONSTRATED THAT THIS ISSUE IS MOST LIKELY RELATED TO A FAULTY INTERNAL CELL PAIR. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPENED TO ADDRESS THE ISSUE. THIS IS ONE OF TWO REPORTS (3007042319-2014-00591 AND -2014-00592) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS (3007042319-2014-00591 AND 3007042319-2014-00592) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    APPROXIMATELY THIRTEEN 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. A PRELIMINARY REVIEW OF THE CONTROLLER LOG FILES REVEALED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332576 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BAT029217- BATTERY| BAT029312- BATTERY