BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1932620 · Received December 20, 2010

    Report

    Report Number
    6000001-2010-06037
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 13, 2010
    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
    PHYSICIAN

    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). THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH DAMAGED BATTERIES WAS CONFIRMED BUT WAS NOT DUPLICATED THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). THIS DEVICE IS A 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)(6) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A DAMAGED BATTERIES. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THIS CONDITION INTERRUPTED DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS 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