BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2364900 · Received December 9, 2011

    Report

    Report Number
    6000001-2011-40277
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. 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). DEVICE EVALUATION: THE REPORT CONDITION OF FAILURE CODE 302:435:118:0003 WAS NEITHER CONFIRMED NOR REPRODUCED DURING PRODUCT EVALUATION. AS A RESULT THE ASSIGNABLE CAUSE WAS NOT IDENTIFIED. NO REPAIRS WERE NEEDED, HOWEVER, THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD WAS REPLACED AS A PRECAUTIONARY MEASURE. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE BIOMED TECHNICIAN REPORTED A COLLEAGUE INFUSION PUMP WITH A 302:435:118:0003 FAILURE CODE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS 6.13.92.

    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