BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4141834 · Received October 4, 2014

    Report

    Report Number
    1416980-2014-34521
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION NOTED FLUID IN THE BAG THAT CONTAINED THE DEVICE. THE LEAK WAS DISCOVERED TO BE COMING FROM AN UNTIGHTENED BLUE WINGED LUER CAP. A FUNCTIONAL LEAK TEST WAS PERFORMED BY FILLING THE DEVICE WITH WATER AND TIGHTENING THE BLUE WINGED LUER CAP. THE NEXT DAY THERE WERE NO SIGNS OF A LEAK FROM THE LUER CAP. THE REPORTED CONDITION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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 LARGE VOLUME FOLFUSOR HAD LEAKED FLUOROURACIL INTO THE OVERPOUCH. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621752 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14G012

    Patients

    Seq Age Sex Outcome Treatment
    1