BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IS CAN SPHERASORB C02 ABSORBENT CANISTER

    MDR report key: 1996335 · Received January 31, 2011

    Report

    Report Number
    1319447-2011-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 31, 2011
    Manufacturer
    INTERSURGICAL, INC.
    Product Code
    CBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE PRODUCT COMPLAINT AND EVALUATION OF THE ABSORBER, THE PRODUCT IS BEING RECALLED. PRODUCT THAT WILL BE RECALLED WILL BE RELABELED WITH WARNINGS NOT TO USE ON THE GE-ADU AND ANMEDIC ANESTHESIA MACHINES. DURING SHIPPING IT WAS DISCOVERED THAT THE GRANULES WILL COMPRESS THE PAD AND ESCAPE INTO THE WATER TRAP AND POTENTIALLY INTO THE INSPIRATORY LIMB OF A BREATHING CIRCUIT. IS CANS TO BE MANUFACTURED WITH TWO FOAM PADS INSTEAD OF ONE IN THE BOTTOM OF THE CAN. A SCREEN WILL ALSO BE ADDED TO THE BOTTOM OF THE IS CAN BY THE WATER TRAP TO FURTHER PREVENT THE GRANULES FROM ESCAPING. THIS WILL ALLOW THE ABSORBER TO BE USED ON THE GE-ADU AND ANMEDIC ANESTHESIA MACHINES.

    Description of Event or Problem · 1

    DURING THE PRE-USE CHECK OF THE ABSORBER ON THE ANESTHESIA MACHINE, IT WAS DISCOVERED THAT GRANULES WERE EXITING THE EXPIRATORY PORT ON THE ABSORBER AND ENTERING THE BREATHING CIRCUIT. THIS INCIDENT DID NOT OCCUR DURING PATIENT USE BUT THE RISK IS FOR THE PATIENT TO INHALE THE ABSORBENT GRANULES. THIS APPLIES ONLY TO THE GE-ADU AND ANMEDIC Q SYSTEMS ANESTHESIA MACHINES. THE FACILITY WHERE THIS OCCURRED IS USING A BREATHING FILTER IN THE BREATHING CIRCUIT THAT WOULD PREVENT THE GRANULES FROM BEING INHALED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IS CAN SPHERASORB C02 ABSORBENT CANISTER ABSORBENT CANISTER CBL INTERSURGICAL, INC. 2196 1101426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other