BEUDAMED
    FDA Adverse Event Death Summary report: N

    HMII LVAS EUROPE

    MDR report key: 1686141 · Received May 12, 2010

    Report

    Report Number
    2916596-2010-00112
    Event Type
    Death
    Date Received
    May 12, 2010
    Date of Event
    April 17, 2010
    Report Date
    April 19, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOG FILE WAS DOWNLOADED FROM THE PT'S SYSTEM CONTROLLER AND CONTAINED APPROXIMATELY 1 HOUR AND 50 MINUTES OF EVENTS, THE FIRST TIME STAMP WAS AT 49 DAYS 18 HOURS AND 40 MINUTES. THROUGHOUT THESE EVENTS VOLTAGES REMAINED AT FUNCTIONAL LEVELS IN THE 13.0 - 13.1 VOLT RANGE. THE SET SPEED WAS AT 9000 RPMS AND THE ACTUALLY SPEED WAS CAPTURED AT APPROXIMATELY 9000 RPMS FOR THE MAJORITY OF THE LOG FILE. THE LOG FILE ALSO REVEALED THE LOW FLOW HAZARD WAS ACTIVE THROUGHOUT, WITH RECORDED FLOWS IN THE 0 - 1 LPM RANGE. TOWARDS THE END OF THE LOG FILE ALARM RESET BECAME ACTIVE AND WAS FOLLOWED BY EVENTS WITH POWER CABLE DISCONNECT WHICH IS CONSISTENT WITH THE REPORT OF THE PT BEING FOUND. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION REPORT IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 2 MONTHS POST-IMPLANT, THE PT WAS AT HOME FOUND EXPIRED, SITTING ON HIS COUCH IN HIS LIVING ROOM, WHILE CONNECTED TO THE POWER MODULE WITH NO BATTERY CLIPS LYING ON A TABLE NEXT TO HIM. DUE TO A LOUD AND AUDIBLE ALARM, THE POWER MODULE HAS BEEN DISCONNECTED FROM WALL POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HMII LVAS EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693 88526

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death