BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1030827 · Received April 17, 2008

    Report

    Report Number
    6000001-2008-00248
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    December 3, 2007
    Report Date
    March 21, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILLED UPON COMPLETION OF THE EVAL, OR IF ANY ADD'L DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A FAILURE CODE 703. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PT INFUSION. ACCORDING TO THE HOSP REP, NO PT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADD'L INFO OR CONTACT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1