BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDISORB MULTI ABSORBER

    MDR report key: 583647 · Received March 14, 2005

    Report

    Report Number
    583647
    Event Type
    Other
    Date Received
    March 14, 2005
    Date of Event
    February 16, 2005
    Report Date
    February 24, 2005
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSF
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE PATIENT ENTERING THE OPERATING ROOM, A ROUTINE ANESTHESIA MACHINE CHECK WAS PERFORMED AND THE MACHINE WAS FULLY FUNCTIONAL. THE PATIENT WAS BROUGHT TO THE OR. DURING INDUCTION OF ANESTHESIA, THE ANESTHESIA TECHNICIAN CHANGED THE MULTI ABSORBER. AN ENDOTRACHEAL TUBE, ETT, WAS PLACED BY THE ANESTHESIOLOGIST AND CONFIRMATION OF THE ETT PLACEMENT IN THE TRACHEA WAS MADE BY BILATERAL BREATH SOUNDS AND POSITIVE END-TIDAL CO2. WITHIN MOMENTS, ELEVATED PEAK INSPIRATORY PRESSURES WERE NOTED. MEDICATIONS WERE GIVEN, ETT WAS REMOVED AND PATIENT WAS VENTILATED BY MASK. THE PATIENT WAS RE-INTUBATED, AND HAD ONE MORE EPISODE OF THE SAME CIRCUMSTANCES. A CHEST X-RAY WAS DONE AND WAS NEGATIVE. THE ETT WAS AGAIN REMOVED, AND PATIENT VENTILATED BY MASK. THE ETT WAS REPLACED AGAIN, AND THERE WAS ONE MORE EPISODE OF SAME PROBLEMS DESCRIBED ABOVE. THE SURGERY WAS CANCELLED. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. THERE WERE NO SEQUELAE NOTED. LATER WHILE AN ANESTHESIA TECHNICIAN WAS CLEANING THE OR ROOM, IT WAS DISCOVERED THAT MICROFOAM WAS TAPED ON 2 BOTTOM OPENINGS OF THE MULTI ABSORBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISORB MULTI ABSORBER CO2 ABSORBER, DISPOSABLE BSF DATEX-OHMEDA 8003138 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR