BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 521867 · Received February 4, 2004

    Report

    Report Number
    6000001-2004-00172
    Event Type
    Malfunction
    Date Received
    February 4, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 26, 2004
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFUSION PUMP WITH FAILURE CODE 12:303:984:0002 DURING PATIENT INFUSION. NO ADDITIONAL CONTACT INFO WAS PROVIDED. THE HOSP REP STATED THERE HAVE BEEN NO REPORTS OF ANY PATIENT INCIDENT INVOLVING THIS PUMP SINCE THE LAST BAXTER SERVICE EVENT. DESPITE BAXTER'S EFFORTS TO OBTAIN ADDITIONAL INFO FROM REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PATIENT'S DEMOGRAPHICS, DIAGNOSIS OR STATUS AND MEDICATION INVOLVED, OR SET UP OF THE INFUSION DEVICE.

    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 UNKNOWN