BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 630295 · Received July 11, 2005

    Report

    Report Number
    6000001-2005-02666
    Event Type
    Malfunction
    Date Received
    July 11, 2005
    Date of Event
    April 28, 2005
    Report Date
    April 28, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH FAILURE CODE 800:320. UPON TESTING IN SERVICE, THE FAILURE CODE WAS FOUND TO BE FAILURE CODE 500:320. IT IS NOT KNOWN IF THE FAILURE OCCURRED WHILE INFUSING ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. COLLEAGUE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN