BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4190152 · Received October 21, 2014

    Report

    Report Number
    1416980-2014-36767
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 26, 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). ADDITIONAL INFORMATION: THIS LOT WAS MANUFACTURED JUNE 18, 2014 TO JUNE 19, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION WITHOUT FLUID IN ITS BLADDER. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS FILLED WITH WATER AND A FUNCTIONAL FLOW TEST WAS PERFORMED; THE DEVICE FLOWED WITHOUT ISSUE. 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 DID NOT FLOW. THIS WAS NOTED DURING INFUSION OF 36.2MG/ML FLUOROURACIL (NON-BAXTER) DILUTED IN 26.5ML OF G5% (NON-BAXTER). THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668609 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F039

    Patients

    Seq Age Sex Outcome Treatment
    1 26.5ML OF G 5% (NON-BAXTER)| 36.2MG/ML FLUOROURACIL (NON-BAXTER)