BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 760078 · Received November 4, 2005

    Report

    Report Number
    6000001-2005-06003
    Event Type
    Malfunction
    Date Received
    November 4, 2005
    Date of Event
    October 7, 2005
    Report Date
    October 7, 2005
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FAILURE CODE 570:320:1844:0000 FOUND DURING BIOMED TESTING. THERE HAVE BEEN NO INCIDENT REPORTS FILED SINCE THE LAST BAXTER SERVICE EVENT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP COLLEAGUE VOLUMETRIC INFUSION PUMP FRN BAXTER HEALTHCARE 2M8161 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA