BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 6053983 · Received October 25, 2016

    Report

    Report Number
    1416980-2016-16624
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 28, 2016
    Report Date
    December 1, 2016
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LOT WAS MANUFACTURED SEPTEMBER 17, 2015-SEPTEMBER 18, 2015. THE DEVICE WAS RECEIVED FOR EVALUATION WITH APPROXIMATELY 120 ML OF FLUID IN THE BLADDER. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED ¿VAP NEEDLE TUBE¿ WAS NOT RECEIVED AT THE PLANT. A FUNCTIONAL LEAK TEST WAS PERFORMED AND THE DEVICE OPERATED WITHIN SPECIFICATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME FOLFUSOR LEAKED. THIS OCCURRED DURING PATIENT USE. IT WAS STATED THAT IT WAS LEAKING FROM THE CONNECTION. THE FOLFUSOR WAS FILED WITH AN UNKNOWN AMOUNT OF FLUOROURACIL. 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
    706691 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 15J026

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL