BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 648453 · Received November 28, 2005

    Report

    Report Number
    6000001-2005-07277
    Event Type
    Malfunction
    Date Received
    November 28, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 3, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNSPECIFIED FAILURE CODES ON THIS COLLEAGUE INFUSION PUMP IN REFERENCE TO THE URGENT PRODUCT RECALL LETTER DATED 7/20/2005.

    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