BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3790210 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14462
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 14A059 WAS MANUFACTURED JANUARY 28, 2014 ¿ JANUARY 29, 2014. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A PHOTOGRAPH OF THE DEVICE WAS PROVIDED FOR EVALUATION AGAINST THE REPORTED CONDITION. THE VISUAL INSPECTION WAS ABLE TO VERIFY THE CONDITION OF A RUPTURE. THE CAUSE WAS UNABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE ACTUAL SAMPLE IS NOT AVAILABLE FOR EVALUATION; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED BY THE CUSTOMER AND EVALUATION OF THE PHOTOGRAPHS IS IN PROGRESS. UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADDER OF A LARGE VOLUME FOLFUSOR RUPTURED. THIS OCCURRED DURING PATIENT INFUSION OF FLUOROURACIL (1140MG IN 220ML 0.9% NACL). THE INFUSION WAS EXPECTED TO LAST 22 HOURS. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267226 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14A059

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL AND 0.9% NACL