BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3883527 · Received June 19, 2014

    Report

    Report Number
    1416980-2014-19449
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OCCURRENCE DATE WAS BETWEEN (B)(6) 2014. THE LOT 13N013 WAS MANUFACTURED DECEMBER 2, 2013 ¿ DECEMBER 3, 2013. THERE WERE NO NONCONFORMITIES, FAILURES, REWORK, OR DEVIATIONS DOCUMENTED IN THE MANUFACTURING BATCH RECORDS ASSOCIATED WITH THE REPORTED PROBLEM. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESSES, EQUIPMENT, OR RAW MATERIALS DOCUMENTED IN THE LOT 13N013 BATCH RECORDS THAT COULD BE ASSOCIATED WITH THE REPORTED PROBLEM 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 UNDERINFUSED. THE REPORTER STATED THE INFUSION WAS CHECKED AT 24 HOURS AND 48 HOURS AND ALLOWED THE INFUSION TO COMPLETE WITH AN ADDITIONAL 24 HOURS (72 HOUR INFUSION). THIS OCCURRED DURING INFUSION OF FLUOROURACIL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361617 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N013

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL