BEUDAMED
    FDA Adverse Event Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3143251 · Received June 3, 2013

    Report

    Report Number
    3007042319-2013-00090
    Date Received
    June 3, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 5, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO HEARTWARE, THEREFORE ANALYSIS COULD NOT BE CONDUCTED OR REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE REPORTED HVAD CONTROLLER IN RELATION TO THE REPORTED EVENT. THE PRODUCT REMAINS CONNECTED TO THE PATIENT AND THEREFORE IS NOT AVAILABLE FOR RETURN TO HEARTWARE. THE REPORTED EVENT FOR A CONTROLLER WITH AN UNKNOWN SERIAL NUMBER FOR A BATTERY "POWER DISCONNECT" CANNOT BE CONFIRMED, AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, THE ROOT CAUSE FOR THE POWER DISCONNECT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME; HOWEVER, IT IS LIKELY RELATED TO THE PATIENT DROPPING THE CONTROLLER. THIS EVENT WAS REPORTED VIA INTERMACS. HEARTWARE IS PROVIDING THIS INFORMATION AS A FINAL RESPONSE. PRODUCT REMAINS CONNECTED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE CONTROLLER REMAINS WITH THE PATIENT AND IS THEREFORE NOT AVAILABLE FOR TESTING AND ANALYSIS. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMS THAT THE UNIT MET ALL SPECIFICATIONS FOR RELEASE. A POWER DISCONNECT IS A LOW PRIORITY ALARM THAT OCCURS WHEN 1 OF THE 2 RECOMMENDED POWER SOURCES ARE DISCONNECTED FROM THE CONTROLLER. THIS ALERT HELPS REMIND A PATIENT TO KEEP A BACKUP POWER SOURCE ATTACHED TO THE CONTROLLER BUT IS NOT COLLECTED AS DATA IN THE CONTROLLER LOG FILES. AS SUCH, THE REPORTED EVENT OF POWER DISCONNECT COULD NOT BE CONFIRMED. THERE WERE NO ADDITIONAL ALARMS NOTED RELEVANT TO THE TIME OF THE EVENT. THE REPORT OF AN "INVERTED WAVEFORM", WHICH MAY BE INDICATIVE OF A SUCTION EVENT, WAS ALSO NOT CONFIRMED ON LOG FILE REVIEW.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED A ¿POWER DISCONNECT¿ APPROXIMATELY 17 DAYS POST HEARTWARE BIVAD IMPLANTATION. THE PATIENT WAS REPORTED TO HAVE DROPPED THE LVAD CONTROLLER. AN INVERTED WAVE FORM WAS DEVELOPED AND ¿BATTERY DISCONNECT¿. THE PATIENT EXPLAINED TO THE CLINICAL SPECIALIST THAT THE BAG FELL, BUT THE BAG DID NOT HIT THE GROUND. HIS EXIT SITE IMMOBILIZER WITHSTANDS THE WEIGHT OF THE BAG. THERE WAS NO PHYSICAL POWER DISCONNECT. THE PATIENT AND ALL EQUIPMENT ARE FINE. NO EXCHANGE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244353 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other