BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4240631 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39700
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THIS LOT WAS MANUFACTURED BETWEEN JUNE 17, 2014 AND JUNE 18, 2014. INVESTIGATION SUMMARY: BAXTER RECEIVED ONE UNIT FOR EVALUATION. VISUAL INSPECTION REVEALED NO SIGNS OF PHYSICAL ABNORMALITY. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND THE FLOW RATES WERE FOUND TO BE WITHIN SPECIFICATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR EMPTIED AFTER 24 HOURS INSTEAD OF THE EXPECTED 48 HOURS. THE UNIT WAS FILLED WITH FLUOROURACIL 3350MG AND 5% GLUCOSE (NON BAXTER PRODUCTS), TOTAL FILL VOLUME WAS 96ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724031 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F032

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR