BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3865033 · Received June 11, 2014

    Report

    Report Number
    1416980-2014-18628
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 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

    (B)(4). THIS LOT WAS MANUFACTURED DECEMBER 2, 2013 ¿ DECEMBER 3, 2013. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION WITHOUT ANY SOLUTION IN THE BLADDER. VISUAL INSPECTION SHOWED NO SIGNS OF BLOCKAGE OR PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW TEST WAS PERFORMED AND CONTINUOUS FLOW WAS IMMEDIATELY OBSERVED AT THE DISTAL LUER. 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 DID NOT COMPLETE INFUSION. THE REPORTER STATED THAT DELIVERY STOPPED AFTER APPROXIMATELY 25% OF THE SOLUTION HAD BEEN INFUSED. THE DEVICE HAD BEEN FILLED WITH 4200MG FLUOROURACIL (NON-BAXTER PRODUCT) AND 9ML 5% GLUCOSE. THE TOTAL FILL VOLUME WAS REPORTED TO BE 93ML AND THE EXPECTED FLOW RATE WAS 2ML/HOUR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344877 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N013

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR FLUOROURACIL| 5% GLUCOSE