BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/DUO-VENT

    MDR report key: 14643152 · Received June 9, 2022

    Report

    Report Number
    14643152
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    April 19, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FPA
    UDI-DI
    00085412565637
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AN IV CHEMOTHERAPY DRUG WAS NOTED TO BE DRIPPING OUTSIDE OF THE BAXTER INTERNATIONAL INC. CLEARLINK/DUO-VENT SOLUTION TUBING SET DURING ADMINISTRATION. STAFF VERIFIED THE DRIP WAS COMING FROM THE BOTTOM OF THE CHAMBER. INFUSION STOPPED, CLEANED UP WITH CHEMO SPILL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055894 CLEARLINK/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER INTERNATIONAL INC. 2R8875 (10)R22A02062 00085412565637

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Unknown