BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO

    MDR report key: 2950027 · Received February 4, 2013

    Report

    Report Number
    2950027
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HUNG A BAG OF AMIODARONE. A FOREIGN BODY WAS NOTICED WHEN THE INFUSION PUMP STARTED TO BEEP. IT WAS DIFFICULT TO SEE BUT LOOKED LIKE PIECE OF CARDBOARD. PHARMACY DETERMINED IT WAS NOT FROM THE AMIODARONE BUT FROM THE IV TUBING ITSELF.THE OBJECT LOOKS LIKE A PIECE OF CARDBOARD THAT IS IN THE IV TUBING BELOW THE CHECK VALVE, WHICH LEADS US TO BELIEVE THAT IT WAS IN THE IV TUBING AND NOT THE AMIODARONE DRIP. IF THE FLOATER HAD COME FROM THE DRIP IT WOULD HAVE PROBABLY BEEN CAUGHT IN THE CHECK VALVE. ALSO THERE IS NO CARDBOARD ALLOWED NEAR THE HOOD IN THE OR IV ROOM, AND BOTH THE TECH AND PHARMACIST INVOLVED DID CHECK FOR FLOATERS PRIOR TO THE DRIP BEING DISPENSED. PER THE OR STAFF, THEY USE THE BAXTER CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET 2C8537A WHICH IS 109 INCHES WITH 3 LUER ACTIVATED VALVES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NORMAL STERILE PROCEDURE OF INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46956 CLEARLINK CONTINU-FLO SET, ADMINISTRATION, IV FPA BAXTER HEALTHCARE CORPORATION 2C8537S *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR CARDIAC DRUGS