BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1870843 · Received September 28, 2010

    Report

    Report Number
    1870843
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 28, 2010
    Manufacturer
    TERUMO
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ON A HEART/LUNG BYPASS MACHINE UNDERGOING A BERLIN HEART VASCULAR ACCESS DEVICE (VAD) IMPLANTATION. THE BYPASS WAS INITIATED AND ARTERIAL BLOOD GASES AND ACTIVATED CLOTTING TIME (ACT)LAB VALUES WERE PULLED EVERY THIRTY MINUTES. TWO HOURS LATER,THE PT'S PAO2 WAS 92MMHG, DOWN FROM 209MMHG, WITH NO CHANGE IN BLOOD FLOW, PT TEMPERATURE OR FIO2. SVO2 WAS 76%. THE SHUNT LINE ON THE CDI SENSOR WAS CHECKED FOR KINKS AND TO ENSURE GOOD BLOOD FLOW FOR ACCURATE READINGS. THE OXYGENATOR GAS EXHAUST WAS VERIFIED THAT IT WAS NOT OBSTRUCTED. THE FILL CHAMBER ON THE ISOFLURANE WAS CLOSED AND SWITCHED FROM A WALL MEDICAL AIR AND OXYGEN SUPPLY TO A FULL OXYGEN TANK. A SHUNT LINE WAS OPENED TO TRY TO INCREASE OXYGENATION. THE PROBLEM WAS NOT CORRECTED AND NOTHING COULD BE ESTABLISHED AS AN OUTSIDE CAUSE OF THE OXYGENATOR FAILING. THE BYPASS PROCEDURE WAS TERMINATED ALMOST AN HOUR LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OXYGENATOR DTZ TERUMO * 100427

    Patients

    Seq Age Sex Outcome Treatment
    1 *