BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBCAB IRRIGATION SYSTEM

    MDR report key: 380851 · Received March 11, 2002

    Report

    Report Number
    1221601-2002-00001
    Event Type
    Injury
    Date Received
    March 11, 2002
    Report Date
    March 11, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GE
    Product Code
    FQH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT SINCE THE PRODUCT HAS BEEN CHANGED, THEY CAN NO LONGER REGULATE THE BLOWER. THE WATER STOPPED AFTER THE PRESSURE RELIEF VALVE OPENED. THE PATIENT ALLEGEDLY RECEIVED A CO2 BLOW INTO THE ARTERY AND HAD TO BE PLACED ONTO A HEART-LUNG-MACHINE. THE CUSTOMER REPORTED TO HAVE SET UP THE UNIT ACCORDING TO THE INSTRUCTIONS FOR USE. WHEN THE PRESSURE RELIEF VALVE OPENED, THE CUSTOMER REPORTED PRESSURE BUILD-UP AND BACK-UP INTO THE SALINE BAG. WHEN THE PRESSURE RELIEF VALVE CLOSED, THE CUSTOMER REPORTED THERE WAS NO CO2 AND PRESSURE CUFF WAS USED ON THE SALINE BAG TO INCREASE PRESSURE. THE CUSTOMER SET THE PRESSURE AT 5 BARS, WHICH IS EQUIVALENT TO 72 PSI, WELL ABOVE THE RECOMMENDED PRESSURE SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBCAB IRRIGATION SYSTEM IRRIGATION SYSTEM FQH GENZYME BIOSURGERY A DIVISION OF GE 89-9185K 512632

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention