BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4051359 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29181
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Report Date
    August 8, 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 WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE UNIT FOR EVALUATION. VISUAL INSPECTION NOTED A SOLID WHITE PARTICLE APPROXIMATELY 2.02 MM IN SIZE, FLOATING IN THE FLUID OF THE BLADDER. THE PARTICLE WAS IDENTIFIED TO BE ACRYLIC VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY SCANNING. THE CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICLES WERE OBSERVED INSIDE OF THE BLADDER OF A LARGE VOLUME FOLFUSOR. THIS WAS NOTICED AFTER THE DEVICE WAS FILLED WITH FLUOROURACIL AND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534669 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13H073

    Patients

    Seq Age Sex Outcome Treatment
    1