BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3842330 · Received June 1, 2014

    Report

    Report Number
    3007042319-2014-00567
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 2, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE BATTERIES AND CONTROLLER WERE RETURNED TO HEARTWARE FOR ANALYSIS. BATTERY (B)(4) AND CONTROLLER (B)(4) BOTH PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. BATTERY (B)(4) FAILED FUNCTIONAL TESTING DUE TO A MEMORY CORRUPTION ERROR. THE MEMORY CORRUPTION ERROR OF THIS BATTERY IS AN INCIDENTAL FINDING AND WOULD NOT HAVE CONTRIBUTED TO THIS EVENT. THE MOST LIKELY ROOT CAUSE OF THE CORRUPTION IS A FAULTY INTERNAL COMPONENT ON THE CIRCUIT BOARD. CRITICAL BATTERY ALARMS (PRIOR TO THE REPORTED EVENT DATED) WERE CONFIRMED BY LOG FILE ANALYSIS AND OCCURRED WHILE VARIOUS POWER SOURCES WERE IN USE. THIS MOST LIKELY IS A RESULT OF AN INTERMITTENT COMMUNICATION ERROR BETWEEN THE BATTERY AND THE CONTROLLER DUE TO EXTERNAL INTERFERENCE. LOG FILE REVIEW ALSO REVEALED A CONTROLLER POWER UP/MOTOR START EVENT ON THE REPORTED EVENT DATE WHICH IS NOT ASSOCIATED WITH THE CRITICAL BATTERY ALARMS. THE CAUSE OF THAT POWER LOSS CANNOT BE DETERMINED BASED ON INFORMATION AVAILABLE. A CAPA HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND TWO MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THERE WAS AN ISSUE WITH THE PERFORMANCE OF THE PATIENT'S BATTERIES. THE BATTERIES AND CONTROLLER WERE REMOVED FROM THE PATIENT AND A NEW CONTROLLER AND BATTERIES WERE 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
    320665 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - BATTERY| (B)(4) - BATTERY