BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN ANTI FREE-FLOW INFUSION SET

    MDR report key: 15264789 · Received August 22, 2022

    Report

    Report Number
    15264789
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    July 30, 2022
    Report Date
    August 17, 2022
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT RECEIVED IV FLUIDS WITH DEXTROSE AT 3.9ML/HR. AFTER APPROXIMATELY 14 HRS ON THIS FLUID, LABS NOTED AN ELEVATED BLOOD GLUCOSE LEVEL THAT WAS UNEXPECTED. TUBING, FLUID, & PUMP WERE REMOVED FROM USE. AFTER TESTING, NO ISSUES WERE IDENTIFIED WITH THE PUMP. ON EXAMINATION OF THE EXTENSION SET, IT WAS NOTED THAT A PIECE WAS MISSING FROM THE T-VALVE. THIS WAS THOUGHT TO HAVE CONTRIBUTED TO THE EVENT - ALLOWING FLUID TO FLOW NOT ONLY FROM THE SYRINGE LOADED IN THE PUMP, BUT ALSO FROM THE IV FLUID BAG. UPON FURTHER INVESTIGATION OF UNOPENED SETS, MULTIPLE SETS WERE FOUND MISSING THIS PIECE FROM THE T-VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299684 CODAN ANTI FREE-FLOW INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION 92062-H

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Unknown