BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4130717 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33951
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 5, 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). THE DEVICE HAS BEEN RECEIVED BY BAXTER; EVALUATION IS CURRENTLY IN PROCESS BUT HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. A VISUAL INSPECTION ON THE UNIT SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED ON THE UNIT AND THE FLOW RATE WAS FUND TO BE WITHIN SPECIFICATION. THE REPORTED PROBLEM WAS NOT VERIFIED. 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 LARGE VOLUME FOLFUSOR OVER INFUSED FLUOROURACIL. THE INFUSION WAS NOTED TO BE FINISHED ONE DAY BEFORE THE EXPECTED COMPLETION. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607942 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13H073

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL