BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC

    MDR report key: 2042596 · Received April 6, 2011

    Report

    Report Number
    6000001-2011-02615
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 16, 2010
    Report Date
    March 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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. THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY DEPLETED SET ALARM WAS DISCOVERED AND CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO RESOLVE THE REPORTED CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). THIS INVOLVED A COLLEAGUE INFUSION PUMP WITH A USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.08.92.

    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 A BATTERY DEPLETED SET ALARM, WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP CE FRENC PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1