BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 656909 · Received December 20, 2005

    Report

    Report Number
    6000001-2005-08590
    Event Type
    Malfunction
    Date Received
    December 20, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 28, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH FAILURE CODE 500:320:844:000. IT IS UNKNOWN WHEN THIS FAILURE CODE OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN