BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3896719 · Received June 26, 2014

    Report

    Report Number
    3007042319-2014-00660
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 27, 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT HAS NOT BEEN RECEIVED.

    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.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND EIGHT 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. PRELIMINARY REVIEW OF THE LOG FILES REVEALED THAT THE PATIENT HAD EXPERIENCED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373561 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