BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1862621 · Received October 8, 2010

    Report

    Report Number
    6000001-2010-03877
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 2, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING BAXTER'S REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT, IT WAS DISCOVERED THAT FAILURE CODE 810:04 OCCURRED DURING PROGRAMMING/SET-UP AND DID NOT INTERRUPT DELIVERY.

    Description of Event or Problem · 1

    BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE INFUSION PUMP AND DISCOVERED FAILURE CODE 810:04 ON CHANNEL B. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. DURING A REVIEW OF THE EVENT HISTORY FOR ANOTHER REPORT IT WAS DISCOVERED THAT FAILURE CODE 810:04 OCCURRED DURING AN INFUSION WHICH CAUSED AN INTERRUPTION DURING DELIVERY ON CHANNEL B AND C. THIS COMPLAINT WILL ADDRESS THE OCCURRENCE ON CHANNEL C. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1