BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2364850 · Received December 9, 2011

    Report

    Report Number
    6000001-2011-40274
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    November 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CONDITION WAS CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY. THE CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAIALBLE A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY LOG REVIEW, A COLLEAGUE INFUSION WAS FOUND TO HAVE EXPERIENCED A 18:326:380:0056 FAILURE CODE, WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THIS EVENT. NO ADDITION 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