BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 677539 · Received November 28, 2005

    Report

    Report Number
    6000001-2005-06561
    Event Type
    Malfunction
    Date Received
    November 28, 2005
    Date of Event
    November 4, 2005
    Report Date
    November 8, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    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 AN INFUSION PUMP WITH A FAILURE CODE 12:303:984:0002. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING BIOMED TESTING. THE HOSPITAL REP STATED THEY HAVE NO RECORD OF ANY PT INCIDENT INVOLVONG THE PUMP SINCE THE LAST BAXTER SERVIE EVENT AND NO PT INJURY HAD BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA