BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 677704 · Received November 28, 2005

    Report

    Report Number
    6000001-2005-07198
    Event Type
    Malfunction
    Date Received
    November 28, 2005
    Date of Event
    October 1, 2005
    Report Date
    October 31, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-2/25/05-004-C
    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 TO A PUMP WITH FAILURE CODE 570:320:844:000. IT IS UNKNOWN WHEN THIS FAILURE CODE OCCURRED. THERE WAS NO PT INJURY OR M EDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSP REPRESENTATIVE.

    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