BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3891772 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20088
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURED BETWEEN DECEMBER 2, 2013 AND DECEMBER 3, 2013. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING DID NOT IDENTIFY ANY MALFUNCTION OR ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS FOUND TO HAVE FLOW WHEN THE LUER CAP WAS REMOVED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR EXPERIENCED NO FLOW DURING INFUSION. AFTER ABOUT 24 HOURS APPROXIMATELY 75% OF THE FILLING VOLUME REMAINED INSIDE THE FOLFUSOR; TOTAL FILL VOLUME WAS 93ML. THE FOLFUSOR WAS FILLED WITH 26.88MG FLUOROURACIL DILUTED WITH GLUCOSE 5% (43ML). THE PATIENT DID NOT HAVE THE ENTIRE THERAPY; HOWEVER, 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
    367600 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N013

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL 26.88MG (NON-BAXTER PRODUCT)| GLUCOSE 5% DILUENT (43ML)