BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SODASORB LF CO2 ABSORBENT

    MDR report key: 1245206 · Received October 30, 2008

    Report

    Report Number
    1245206
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    WR GRACE & COMPANY
    Product Code
    BSF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    CRNA REPORTED THAT CONTAINERS OF SODASORB LF (CO2 ABSORBENT) ARRIVE WITH PARTIAL COLOR CHANGE OR SUBSTANTIAL COLOR CHANGE, INDICATING ABSORPTION OF CO2 FROM AMBIENT AIR. ASBORBENT DUST COMING OUT OF OUTER PLASTIC WRAP INDICATES PRESENCE OF A PIN HOLE IN THE OUTER PLASTIC FILM WRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SODASORB LF CO2 ABSORBENT ABSORBER, CARBON DIOXIDE BSF WR GRACE & COMPANY * CW05-P128-05

    Patients

    Seq Age Sex Outcome Treatment
    1 *