BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1820422 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02866
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 27, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE INVESTIGATION FOR THE REPORTED PROBLEM IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER AN EVALUATION WAS PERFORMED AT THE CUSTOMER LOCATION BY A BAXTER FIELD SERVICE ENGINEER. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A BATTERY ISSUE, AND DETERMINED THE ROOT CAUSE TO BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED A BATTERY ISSUE. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THE REPORTED CONDITION OCCURRED. REVIEW OF THE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION INTERRUPTED DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.08.92, WHICH IS CLASSIFIED AS REMEDIATED. 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