BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2221638 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20537
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 500:320 WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO A DEFECTIVE MAIN SPEAKER HARNESS. THE MAIN SPEAKER HARNESS WAS REPLACED TO CORRECT THIS CONDITION. THIS IS INVOLVING A PUMP WITH SOFTWARE VERSION 5.04.00 WHICH IS CATEGORIZED AS UNREMEDIATED. A DEVICE HISTORY REVIEW WAS PERFORMED FINDING ONE EXCEPTION DURING MANUFACTURING; THE 'OPEN' KEY WAS NOT FUNCTIONING AND THE USER INTERFACE PRINTED CIRCUIT BOARD CHANNEL A WAS CHANGED & PUMP PASSED SUBSEQUENT TESTING AND WAS THEN FOUND TO BE PERFORMING AS DESIGNED BEFORE RELEASE. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 500:320. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. ACCORDING TO THE FACILITY REPRESENTATIVE, THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. 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 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1