BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM

    MDR report key: 2423687 · Received January 13, 2012

    Report

    Report Number
    MW5023851
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 13, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSE SPIKED 1 LITER BAG OF LACTATED RINGERS (BAXTER: LOT C854604, EXP: MAY 2013) WITH A BAXTER SECONDARY MEDICATION ADMINSTRATION SET (2C7461). WHEN THE DRIP CHAMBER WAS SQUEEZED TO PRIME THE LINE, THE CONTENTS OF DRIP CHAMBER APPEARED CLOUDY. THE IV BAG AND LINE WERE THEN SENT TO THE PHARMACY. I TRIED TO REPEAT THE PROBLEM. WITH A NEW SECONDARY ADMINSTRATION SET KEPT IN THE PHARMACY AND NO CLOUDING OCCURRED. I AM UNSURE IF THIS MAY BE AN ISSUE WITH THE IV SOLUTION OR WITH THE ADMINISTRATION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM LACTATED RINGERS USP KPE BAXTER HEALTHCARE CORPORATION C854604
    2 CLEARLINK SYSTEM SECONDARY MEDICATION SET FPA BAXTER HEALTHCARE CORPORATION 2C7461

    Patients

    Seq Age Sex Outcome Treatment
    1