BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1240646 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-03064
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 28, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BY BAXTER FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COLLEAGUE CXE VOLUMETRIC INFUSION PUMP WAS ALARMING AIR-IN-LINE FREQUENTLY DURING USE. THERE WAS NO REPORT FROM THE CUSTOMER THAT THE AIR-IN-LINE ALARM RESULTED IN ANY PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1