BEUDAMED
    FDA Adverse Event Death Summary report: N

    A200SP ABSORBER

    MDR report key: 1619837 · Received March 2, 2010

    Report

    Report Number
    9610531-2010-00001
    Event Type
    Death
    Date Received
    March 2, 2010
    Report Date
    January 3, 2010
    Manufacturer
    PENLON LTD.
    Product Code
    BSF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B) (6) MAN DIED AFTER AN EMERGENCY CRANIECTOMY FOLLOWING A ROAD TRAFFIC ACCIDENT AT THE (B) (6) TRAUMA CENTRE, (B) (6). A ROUTINE CHECK OF THE A200SP ABSORBER WAS CARRIED OUT PRIOR TO THE USE. THE PATIENT'S VITAL SIGNS WERE BEING MONITORED AND WERE WITHIN NORMAL LIMITS. TWENTY MINUTES LATER, THE FICO2 INCREASED FROM 0 TO 15MMGH AND ETCO2 INCREASED FROM 34 TO 50MMHG. THE SODA LIME IN THE CANISTER HAD NOT CHANGED COLOR AND THE UNIDIRECTIONAL VALVES WERE FUNCTIONING NORMALLY. THE FLOWS WERE THEN INCREASED AND MANUAL VENTILATION WAS INITIATED. ON CLOSER INSPECTION OF CANISTER, ONE OF THE THREE RUBBER SPACERS ON WHICH THE INNER CHAMBER OF THE SODA LIME CANISTER IS SEATED WAS FOUND TO BE MISSING. AS A CONSEQUENCE THE PATIENT HAD BEEN REBREATHING CO2. ONCE THE SPACER WAS REPLACED THE FICO2 AND ETCO2 NORMALIZED. THE HOSPITAL ACKNOWLEDGED THE MISSING SPACER WAS PROBABLY BEEN DUE TO HUMAN ERROR WHEN THE CANISTER WAS CLEANED OR REFILLED WITH SODA LIME. THE INSTRUCTIONS FOR USE FOR THIS DEVICE STATE THE USER SHOULD CHECK THE THREE SPACERS ARE IN PLACE BEFORE USE. OUR DISTRIBUTOR HAS CONFIRMED THAT THEY PROVIDED TRAINING FOR THE STAFF AT THE HOSPITAL. THE HOSPITAL DO NOT WISH TO RETURN THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A200SP ABSORBER ABSORBER CARBON DIOXIDE BSF PENLON LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death