BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1575134 · Received January 12, 2010

    Report

    Report Number
    6000001-2010-00046
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    December 15, 2009
    Report Date
    December 16, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. (B) (4)

    Description of Event or Problem · 1

    ON DECEMBER 16, 2009 THE FACILITY'S BIOMEDICAL ENGINEER REPORTED TO BAXTER GLOBAL TECHNICAL SERVICES THAT ON (B) (6) 2009 ONE COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP IN WHICH FAILURE CODE 313:425:250:002 OCCURRED. THE REPORTED CONDITION OCCURRED DURING PATIENT THERAPY IN THE CORONARY INTENSIVE CARE UNIT. PATIENT THERAPY WAS INTERRUPTED AS A RESULT OF THIS FAILURE. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE FOR THIS DEVICE IS CURRENTLY NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1