BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4141077 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34451
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED APRIL 21, 2014 ¿ APRIL 23, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION WITH APPROXIMATELY 96 ML OF FLUID WITHIN ITS BLADDER. A VISUAL INSPECTION WAS PERFORMED AND SHOWED NO DEFECTS RELATED TO THE REPORTED PROBLEM. THE DISTAL LUER CAP WAS REMOVED AND NORMAL FLOW WAS OBSERVED. 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). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR EXPERIENCED A NO FLOW. THIS OCCURRED DURING PRIMING, AFTER THE DEVICE WAS FILLED WITH FLUOROURACIL (NON-BAXTER PRODUCT) AND SODIUM CHLORIDE (NON-BAXTER PRODUCT) TO A TOTAL VOLUME OF 96 ML. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618265 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14D053

    Patients

    Seq Age Sex Outcome Treatment
    1