BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS LATEX-FREE INFUSION SET TWO SMARTSITE

    MDR report key: 1153483 · Received September 8, 2008

    Report

    Report Number
    MW5008238
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SECONDARY MEDICATION BACKED UP INTO THE PRIMARY INFUSION. THE ALARIS IV PUMP WAS SET TO INFUSE KCL 10 MEQ/HR AS SECONDARY PIGGYBACK TO PRIMARY INFUSION OF 0.9% SODIUM CHLORIDE. THE SECONDARY PUMP SETTINGS WERE ENTERED AS 100ML/HR FOR RATE AND 100ML FOR VOLUME TO BE INFUSED. AFTER APPROXIMATELY 15 MINUTES, THE IV POTASSIUM BAG WAS ALMOST EMPTY, HOWEVER THE PUMP READ 82ML VTBI. THE DRIP RATE WAS VISUALIZED TO BE RUNNING FASTER THAN 100ML/HR AND THERE WAS CONCERN THAT THE PATIENT HAD RECEIVED 80-90ML OF POTASSIUM WITHIN 15 MINUTES. THE PATIENT WAS PLACED ON TELEMETRY AND RECEIVED CALCIUM GLUCONATE 3GMS PROPHYLACTICALLY. THE ALARIS PUMP INFORMATION WAS DOWNLOADED AND CONFIRMED THE ABOVE SETTINGS. WHEN THE PUMP WAS TURNED ON WITH THE PUMP DOOR CLOSED AND THE ORIGINAL TUBING STILL IN PLACE, IT WAS OBSERVED THAT THE IVPB WAS BACKING UP INTO THE PRIMARY INFUSION. THIS WAS CONFIRMED WHEN THE 0.9% PRIMARY INFUSION WAS TESTED BY THE LABORATORY AND FOUND TO HAVE POTASSIUM IN THE BAG. THE PRIMARY INFUSION WAS HANGING ON A 37" HANGER AND THE SECONDARY MEDICATION SET WAS HANGING AT LEAST 9 1/2 INCHES ABOVE THE PRIMARY INFUSION AT THE TIME THAT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS LATEX-FREE INFUSION SET TWO SMARTSITE INFUSION SET FPA ALARIS MEDICAL SYSTEMS, INC. 2420-0500 604238-100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening BAXTER CLEARLINK SYSTEM SECONDARY MEDICATION SET| -2C7461- WITH 37 INCH HANGER| AND MALE LUER LOCK ADAPTER