BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMSORB 1.0 KG CARTRIDGE

    MDR report key: 308867 · Received December 13, 2000

    Report

    Report Number
    MW1020585
    Event Type
    Injury
    Date Received
    December 13, 2000
    Date of Event
    November 27, 2000
    Report Date
    November 27, 2000
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    CBL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FIRST CASE IN MORNING AFTER INDUCTION OF GENERAL ANESTHESIA AND REDUCTION OF GAS FLOWS TO MAINTENANCE N2O 0.4 L/MIN+ O2 0.64 MIN; THE INSPIRED CO2 LEVEL WAS NOTED TO BE ELEVATED AND RISING, AS WELL AS THE END TIDAL CO2. RECHECK OF THE INSPIRATORY AND EXPIRATORY VALVES ON THE ANESTHESIA MACHINE REVEALED NO PROBLEM. THE CO2 ABSORBANT DID NOT APPEAR TO BE EXHAUSTED. INCREASING GAS FLOWS IMPROVED THE PROBLEM SOMEWHAT. AN ANESTHESIA TECH CALLED IN IMMEDIATELY KNEW WHAT THE PROBLEM WAS AS ANOTHER ANESTHESIOLIGST HAD EXPERIENCED THE SAME PROBLEM 6 DAYS AGO: THE "TRIAL" CO2 ABSORBANT CARTRIDGE LEAVES A GAP BETWEEN IT AND THE CANNISTER, ALLOWING EXPIRED GASES TO BYPASS THE ABSORBANT, RESULTING IN THE ELEVATED INSPIRED CO2. A CHANGE TO USUAL SYSTEM OF FILLING THE CANNISTER DIRECTLY WITH ABSORBANT ALLEVIATED THE PROBLEM IMMEDIATELY. OTHER THAN A TEMPORARY RISE IN BLOOD PRESSURE, THE PT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSORB 1.0 KG CARTRIDGE CO2 ABSORBANT FOR ANESTHESIA MACHINE CBL ABBOTT LABORATORIES, INC. * 670096E

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention