BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3961807 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24491
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURED FEBRUARY 4, 2014 ¿ FEBRUARY 5, 2014. EVALUATION SUMMARY THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION AND LEAK TESTING WERE PERFORMED. TWENTY FOUR HOURS AFTER THE DEVICE WAS FILLED THERE WAS NO EVIDENCE OF A LEAK. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOLFUSOR LEAKED. THIS MALFUNCTION OCCURRED AFTER THE DEVICE WAS FILLED WITH NACL AND 5-FU. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439721 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B023

    Patients

    Seq Age Sex Outcome Treatment
    1