BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1240303 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-03088
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    December 5, 2006
    Report Date
    January 12, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. THE FACILITY HAS DECLINED TO RELEASE THE DEVICE FOR ANALYSIS. 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 READ LOW BATTERY, FAIL CODE 570, DURING AN INFUSION OF D10 WITH POTASSIUM IN A 250ML GA ON A INFANT WHILE ENROUTE TO SURGERY FOR AN UNKNOWN SURGERY. THE PUMP STOPPED WORKING IN SURGERY AND THE TUBING WAS REMOVED FROM THE PUMP. THE INFUSION WAS SET TO RUN BY GRAVITY. THE PATIENT WAS REPORTED TO HAVE RECEIVED 22 ML PRIOR TO LEAVING NICU. THE PATIENT IS REPORTED TO HAVE RECEIVED 18 ML IN SURGERY. UPON RETURN TO THE NICU, 50 ML WERE REPORTED TO BE REMAINING IN THE BAG. THE PATIENT¿S BLOOD GLUCOSE UPON RETURN TO NICU WAS GREATER THAN 600.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Life Threatening| R