BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP

    MDR report key: 1061037 · Received June 12, 2008

    Report

    Report Number
    6000001-2008-00373
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH A FAILURE CODE 500:320:654:0000. THE CUSTOMER REPORTED THAT THIS INCIDENT OCCURRED DURING USE ON THE PATIENT, HOWEVER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION AT THIS TIME REGARDING THE STAGE OR IF ANY PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1