BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3961940 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24509
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 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). MANUFACTURE DATE: OCTOBER 9, 2013 ¿ OCTOBER 10, 2013. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION FLUID WAS OBSERVED WITHIN THE PACKAGE THE DEVICE WAS SHIPPED. THE BLUE WINGED LUER CAP WAS NOTED TO NOT BE TIGHTENED. THE LUER CAP WAS TIGHTENED AND THE DEVICE WAS FILLED WITH GREEN COLOR WATER TO TEST FOR LEAKS WITH NO DEFECTS NOTED. THE DEVICE MET SPECIFICATIONS; HOWEVER, THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM WAS THE LOOSE LUER CAP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE CUSTOMER ORIGINALLY REPORTED LOT NUMBER 13G054. HOWEVER, A SAMPLE FROM LOT NUMBER 13K044 WAS RECEIVED FOR EVALUATION. THIS LOT NUMBER (13K044) HAD BEEN WRITTEN ON THE RECEIVED CONTAINER. THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR LEAKED. THIS WAS IDENTIFIED AFTER THE DEVICE WAS FILLED WITH FLUOROURACIL AND SODIUM CHLORIDE (NACL). THE REPORTER DID NOT SPECIFY THE LOCATION OF THE LEAK. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437666 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13K044

    Patients

    Seq Age Sex Outcome Treatment
    1