BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP,COLLEAGUE TRIPLE CHANNELFRENCH - LOANER

    MDR report key: 1935037 · Received December 22, 2010

    Report

    Report Number
    6000001-2010-06091
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    July 5, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FAILURE CODE 814:04 WAS DISCOVERED AND CONFIRMED IN THE PUMP'S EVENT HISTORY. THE ASSIGNABLE CAUSE WAS UNDETERMINED BECAUSE THIS IS A STAY-IN DEVICE. THEREFORE, NO REPAIRS WERE MADE FOR THIS REPORTED CONDITION AS THE DEVICE HAS BEEN REMOVED FROM SERVICE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.06.00.

    Description of Event or Problem · 1

    BAXTER (B)(4) REVIEW OF THE DEVICE EVENT HISTORY FOUND THAT FC 814:04 CAUSED AN INTERRUPTION OF DELIVERY ON A COLLEAGUE INFUSION PUMP. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP,COLLEAGUE TRIPLE CHANNELFRENCH - LOANER PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1