BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER COLLEAGUE

    MDR report key: 2135172 · Received June 15, 2011

    Report

    Report Number
    MW5021028
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 4, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (EIN 250-10489 KP NUMBER 11-20493) FOUND ERROR CODE 810:11, AIR/OCCLUSION SENSOR OUT OF CALIBRATION. PUMP TO BE SENT TO BAXTER HEALTHCARE FOR REPAIR/CALIBRATION OF AIL SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER COLLEAGUE INFUSION PUMP FRN BAXTER HEALTHCARE 2M9161 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Required Intervention