BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUP

    MDR report key: 474279 · Received September 5, 2002

    Report

    Report Number
    6000001-2002-02977
    Event Type
    Malfunction
    Date Received
    September 5, 2002
    Date of Event
    August 1, 2002
    Report Date
    August 12, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFUSION PUMP WITH AN 810:04 FAILURE CODE. INFORMATION WAS REQUESTED BUT DETAILS WERE NOT AVAILABLE REGARDING PATIENT STATUS, MEDICAL INTERVENTION, PATIENT INJURY, MEDICATION INVOLVED, TUBING PRODUCT CODE, INFUSION RATE OR SET UP OF THE INFUSION DEVICE. ADDITIONAL CONTACT INFORMATION WAS REQUESTED BUT NO ADDITIONAL CONTACT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSION PUP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) COLLEAGUE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN