BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 690507 · Received January 23, 2006

    Report

    Report Number
    6000001-2006-01086
    Event Type
    Malfunction
    Date Received
    January 23, 2006
    Date of Event
    December 30, 2005
    Report Date
    December 30, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION, FAILURE CODE 814:04 WAS FOUND IN THE PUMP'S HISTORY. IT IS UNK WHEN THIS FAILURE CODE OCCURRED OT IF THERE WAS NAY PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN