BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3203827 · Received July 3, 2013

    Report

    Report Number
    3007042319-2013-00117
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 6, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Additional Manufacturer Narrative · 1

    HVAD PUMP (B)(4) WAS RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT (B)(4) MET ALL REQUIREMENTS FOR RELEASE. POST-EXPLANT ENGINEERING EVALUATION DID NOT REVEAL ANY CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED HIGH POWER EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES. INDEPENDENT PATHOLOGICAL ANALYSIS CONFIRMED THE PRESENCE OF THROMBUS; HOWEVER, THE ORIGIN OF THIS THROMBUS CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE REVIEW OF THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION LED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO UNDERWENT A PUMP EXCHANGE DUE TO HIGH POWER APPROXIMATELY TEN MONTHS POST HEARTWARE LVAD IMPLANTATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN UNKNOWN INFECTION. WHILE IN THE HOSPITAL, VITAMIN K ANTAGONISTS WERE STOPPED AND LOW MOLECULAR WEIGHT HEPARIN (LOVENOX 0.4 ML X2 PER DAY) WAS STARTED. THE PATIENT¿S ANTI-XA (HEPARIN ASSAY) WAS ABOUT 0.6 AND THE INR WAS ABOUT 1.2-1.7 DURING THIS TREATMENT. TWO WEEKS LATER DURING PREPARATION FOR DISCHARGE, THE NURSE HEARD THE HIGH WATT ALARM (5.5 W). THE HOSPITAL PERFORMED AN ULTRASOUND TO SEARCH FOR THROMBUS, BUT NOTHING WAS FOUND. THE PATIENT¿S ANTICOAGULATION WAS REPORTED TO BE WITHIN GOOD RANGE AT THIS TIME. THE HOSPITAL DECIDED TO ADMINISTER DOBUTAMINE, BUT THERE WAS NO IMPROVEMENT. LOG FILES SUGGESTED THAT PUMP WATTS HAD STARTED TO INCREASE 5 DAYS PRIOR TO THE ALARM. THE SURGEON DECIDED TO PERFORM A PUMP EXCHANGE. THE PUMP WAS OPENED BY THE HOSPITAL AND ONLY FIBRIN WAS SEEN. NO THROMBUS WAS IDENTIFIED. FOLLOWING THE PUMP EXCHANGE, THE PATIENT WAS EXTUBATED AND WAS STABLE IN THE INTENSIVE CARE UNIT (ICU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304620 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R DOBUTAMINE