BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1902712 · Received November 18, 2010

    Report

    Report Number
    6000001-2010-04992
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.01.00. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 550:320:844:0000 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY. THIS CONDITION WAS CAUSED BY A DEFECTIVE MAIN SPEAKER. THE MAIN SPEAKER WAS REPLACED TO CORRECT THIS CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 550:320:844:0000. THE EVENT WAS REPORTED TO HAVE OCCURRED AFTER PATIENT THERAPY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. DURING PRODUCT EVALUATION, A BAXTER SERVICE TECHNICIAN CONFIRMED FAILURE CODE 550:320:844:0000, BUT ALSO FOUND THE PUMP DID NOT AUDIBLY ALARM FOR THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    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