BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLUTION SET

    MDR report key: 3951835 · Received July 13, 2014

    Report

    Report Number
    3951835
    Event Type
    Malfunction
    Date Received
    July 13, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 13, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S IV PRIMARY TUBING LINE BROKE. THE NURSE ENTERED THE PATIENT'S ROOM AND THE PATIENT WAS HOLDING UP HALF OF THE LINE ATTACHED TO THE PERIPHERAL IV (DRIPPING BLOOD), AND HALF OF THE LINE TO THE IV PUMP (DRIPPING IV SOLUTION). THE TUBING BROKE BEHIND THE FIRST OR SECOND PORT OF THE LINE. IT APPEARS THAT THE TUBING FELL OUT OF THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409046 CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 60 DROPS/ML R141308045

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR NO OTHER THERAPIES