BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2364638 · Received December 9, 2011

    Report

    Report Number
    6000001-2011-40259
    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).THE REPORTED CONDITION OF AN 18:326:380:0056 FAILURE CODE WAS CONFIRMED THROUGH A REVIEW OF THE EVENT HISTORY. THE ASSIGNABLE CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE DEVICE HAS BEEN REMOVED FROM SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY LOG REVIEW, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED AN 18:326:380:0056 FAILURE CODE, WHICH INTERRUPTED 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