BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN

    MDR report key: 6947376 · Received October 13, 2017

    Report

    Report Number
    6947376
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 11, 2017
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE A CRITICALLY ILL INFANT WAS RECEIVING PRESSORS FOR HYPOTENSION THE EXTENSION SET PUMP BEGAN TO ALARM (OCCLUSION). BECAUSE OF THE FREQUENT ISSUES WITH CODAN PRODUCTS, THE NURSE BELIEVED THAT THE OCCLUSION WAS DUE TO THE CODAN DEVICE. THE NURSE THEN WENT THROUGH THREE ADDITIONAL DEVICES UNTIL SHE FOUND A 5TH DEVICE WHICH WORKED. THE TUBING WITH THE YELLOW CLAMP AND FILTER WILL NOT FLUSH OR DOES WITH A LOT OF PRESSURE. THE PATIENT EXPERIENCES PROFOUND HYPOTENSION AND HYPERGLYCEMIA DUE TO THE DELAY IN GETTING THE INFANT STARTED BACK ON THEIR GTTS. I HAVE 4 DEFECTIVE DEVICES IN HAND. MANUFACTURER RESPONSE FOR NEEDLEFREE TRIFURCATED MICROBORE EXTENSION SET, (BRAND NOT PROVIDED) (PER SITE REPORTER): SORRY (B)(6), I HATE TO HEAR THIS. DO WE KNOW WHY THE TUBING WAS SWITCHED 'SEVERAL TIMES'? WAS IT FLOWING PRIOR TO THE HOOKUP TO THE PATIENT? DID FILTERS CLOG? I HAVE ATTACHED OUR COMPLAINT FORM AND PLEASE BE AS SPECIFIC AS POSSIBLE SO WE HAVE THE FACTS IN OUR INVESTIGATION. AS FOR THE SAMPLE, IT IS WORTH GOLD TO US. WE NEED IT TO FIGURE OUT A FIX. IF YOU CAN DOUBLE-BAG IT AND SEND IT (B)(6) THAT WOULD HELP US TREMENDOUSLY: PLEASE FORWARD ANY SAMPLES OF ANY FAILURES DIRECTLY TO ME USING (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728121 CODAN SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION 73783

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR