BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    MDR report key: 2003277 · Received February 28, 2011

    Report

    Report Number
    6000001-2011-01427
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF FAILURE CODE 809:00, WHICH INTERRUPTED DELIVERY, WAS CONFIRMED DURING PRODUCT EVALUATION. HOWEVER, THE ROOT CAUSE WAS NOT IDENTIFIED. THE PUMP HEAD MODULE (PHM) WAS REPLACED AS A PRECAUTION. THE USER INTERFACE MODULE SOFTWARE VERSION IS 5.08.92. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER, A BAXTER FIELD SERVICE TECHNICIAN REPAIRED THIS DEVICE AT THE CUSTOMER SITE. DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED FAILURE CODE 809:00, INTERRUPTING DELIVERY. THERE WAS NO PATIENT INVOLVEMENT. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1