BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2299480 · Received October 18, 2011

    Report

    Report Number
    6000001-2011-31724
    Event Type
    Malfunction
    Date Received
    October 18, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED BY SERVICE THROUGH THE EVENT HISTORY. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS NOT IDENTIFIED AS THE CONDITION WAS NOT RELATED TO THE CUSTOMER REPORTED CONDITION. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.CORRECTION G5: K041191.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED, AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR IS SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE IS CURRENTLY BEING EVALUATED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED AN UPSTREAM OCCLUSION SET ALARM ON CHANNEL C, WHICH INTERRUPTED DELIVERY. THIS ALARM MAY HAVE BEEN A FALSE ALARM. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.08.92. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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