BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1932539 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05978
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    January 7, 1997
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 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 FAILURE CODE 808:04 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY BY A BAXTER SERVICE TECHNICIAN. THE ROOT CAUSE OF THIS CONDITION WAS ASSIGNED TO A DEFECTIVE PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THIS CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.06.00.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED FAILURE CODE 808:07. BAXTER'S REVIEW OF THE DEVICE EVENT HISTORY FOUND THAT FAILURE CODE 808:04 INTERRUPTED DELIVERY. 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 COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1