BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS/CARDINAL HEALTH

    MDR report key: 690285 · Received February 27, 2006

    Report

    Report Number
    MW1038155
    Event Type
    Other
    Date Received
    February 27, 2006
    Report Date
    February 27, 2006
    Manufacturer
    ALARIS/CARDINAL HEALTH
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BLUE THUMB SLIDE ON SETS WERE TOO TIGHT CAUSING THE INFUSION SET TO PUSH AWAY FROM THE MECHANISM AND NOT ALLOWING THE BLUE SLIDE TO OPEN. WE ALSO FOUND THAT THE BAD SETS DID NOT ALLOW THE FLUIDS TO FLOW FREELY AND CAUSED UPSTREAM OCCLUSION ALARMS WITH THE SIGNATURE INFUSION PUMPS. AFFECTED SETS WERE MANUFACTURED ON 12-05 AND 1-06. TESTED INFUSION SETS IN BIOMED SHOP AND VERIFIED PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS/CARDINAL HEALTH INFUSION SET FPA ALARIS/CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other