BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CONSOLE

    MDR report key: 1220048 · Received October 24, 2008

    Report

    Report Number
    1220048
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 24, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIO-THORACIC SURGERY, THE PATIENT WAS ON THE HEART/LUNG PUMP. THE PERFUSIONIST WAS ASKED TO DECREASE THE FLOW. WHEN SHE WAS ASKED TO TURN THE FLOW BACK UP, THE SPEED KNOB ON THE CENTRIFUGAL PUMP CONSOLE FAILED TO INCREASE THE FLOW AND THE RPM'S (SPEED) TO A REGULAR LEVEL. THE PRESSURE STAYED AT ZERO. ALL CONNECTIONS WERE CHECKED. THE PUMP WAS TURNED ON AND OFF AND IT RESUMED NORMAL OPERATION. A FIBRIN CLOT FORMED IN THE VENOUS RESERVOIR, OBSTRUCTING THE OUTFLOW. THE RESERVOIR NEEDED TO BE CHANGED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CONSOLE PUMP, CENTRIFUGAL KFM MEDTRONIC, INC. 560 *
    2 * CARDIOTOMY RESERVIOR, VENOUS KFM MEDTRONICS PERFUSION SYSTEMS CB4U66R7-REVISION *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR