BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2973645 · Received February 14, 2013

    Report

    Report Number
    2973645
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 14, 2013
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHEN PRIMING PCA TUBING, PRIOR TO ATTACHING TO PATIENT, A SUSPICIOUS, BROWNISH-BLACK SUBSTANCE/PARTICULATE WAS NOTED INSIDE THE TUBING. THE TUBING AND PACKAGING WERE SEQUESTERED, AND NEW TUBING WAS USED TO START PCA INFUSION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66164 ALARIS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. * 12116483

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR