BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SODASORB LF

    MDR report key: 1570070 · Received December 4, 2009

    Report

    Report Number
    1570070
    Event Type
    Malfunction
    Date Received
    December 4, 2009
    Date of Event
    December 3, 2009
    Report Date
    December 4, 2009
    Manufacturer
    WR GRACE
    Product Code
    BSF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    NURSING ASSISTANT WAS PREPARING TO CHANGE CO2 ABSORBENT ON ANESTHESIA MACHINE AND OBSERVED THAT UNOPENED CONTAINER OF ABSORBENT HAD CHANGED COLOR, HENCE NOT USEABLE. EXAMINATION REVEALED THAT THERE WAS A PERFORATION IN THE OUTER PLASTIC FILM WRAP COVERING THE CONTAINER. TWO PREVIOUS REPORTS ON DIFFERENT LOT NUMBERS OF THIS ITEM HAVE BEEN FILED. MANUFACTURER RESPONSE (AS PER REPORTER) FOR CO2 ABSORBENT, SODASORB LFLEFT MESSAGE FOR MANUFACTURER'S REPRESENTATIVE AND EXPECT A CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SODASORB LF CO2 ABSORBENT BSF WR GRACE * CX01-P128-08

    Patients

    Seq Age Sex Outcome Treatment
    1 *