BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR LV5

    MDR report key: 1240078 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06027
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    March 27, 2007
    Report Date
    April 4, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT HAS BEEN REQUESTED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED, EVALUATION RESULTS WILL BE PROVIDED IN A FOLLOW UP REPORT. A BATCH REVIEW HAS BEEN CONDUCTED BY THE MANUFACTURING QA GROUP WHICH REVEALED THAT THE LOT PASSED ALL RELEASE CRITERIA. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    BAXTER-GERMANY RECEIVED A CUSTOMER REPORT CONCERNING AN OVERINFUSION INCIDENT DURING PATIENT USE. THE FLOW WAS NEARLY 12 HOURS FASTER THAN THE EXPECTED FLOW DURATION. THE INFUSOR WAS FILLED WITH FLUOROURACIL 4392.00 MG AND 5.000 I.E. HEPARIN IN A FINAL VOLUME OF 240 ML SODIUM CHLORIDE. NO INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR LV5 ELASTOMERIC INFUSION SYSTEM MEB BAXTER HEALTHCARE CORPORATION NA 07A025

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR