BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER IV FLUID BAGS

    MDR report key: 6208533 · Received December 28, 2016

    Report

    Report Number
    6208533
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 23, 2016
    Manufacturer
    BAXTER INTERNATIONAL INC
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN WAS HANGING A NEW FLUID BAG FOR NICU PATIENT. THE BAG WAS SPIKED WITHOUT ANY PROBLEMS. THE BAG WAS THEN PLACED ON THE IV POLE TO PRIME. ONCE THE BAG WAS PLACED ON THE IV POLE, THE SPIKE FROM THE TUBING PUNCTURED A HOLE IN THE IV BAG. PHARMACY WAS NOTIFIED AND A NEW BAG AND TUBING WERE OBTAINED FOR THIS PATIENT. THESE BAGS ARE RELATIVELY NEW TO OUR ORGANIZATION AND THEY ARE FLIMSY. WE SWITCHED FROM A DIFFERENT MANUFACTURER TO BAXTER AND HAVE HAD PROBLEMS WITH THE BAXTER PRODUCT. IT SEEMS THE BAGS ARE MUCH MORE EASILY PUNCTURED VS. THE PREVIOUS MANUFACTURER'S PRODUCT. PHARMACY HAS ALSO REPORTED ISSUES WITH THESE BAXTER IV BAGS INCLUDING LEAKAGE WITH NEW BAGS. MANUFACTURER RESPONSE FOR IV BAG, BAXTER IV FLUID BAGS (PER SITE REPORTER): PHARMACY MAY HAVE BEEN IN CONTACT WITH BAXTER REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859952 BAXTER IV FLUID BAGS CONTAINER, IV LXG BAXTER INTERNATIONAL INC Y206375

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES