BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 531419 · Received March 5, 2004

    Report

    Report Number
    6000001-2004-00392
    Event Type
    Malfunction
    Date Received
    March 5, 2004
    Date of Event
    February 1, 2004
    Report Date
    February 19, 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

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

    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