BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3171757 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15483
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 22, 2013
    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). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS RECEIVED FOR EVALUATION, HOWEVER, PART OF THE TUBING AND THE CONNECTED WHITE LUER WERE NOT INCLUDED WITH THE RETURNED SAMPLE. THE PART OF THE SAMPLE THAT WAS RETURNED WAS VISUALLY INSPECTED, WHICH DID NOT IDENTIFY ANY EVIDENCE OF DETACHMENT. THE REPORTED PROBLEM COULD NOT BE CONFIRMED, AS ONLY PART OF THE DEVICE WAS RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A LARGE VOLUME FOLFUSOR HAD DETACHED. THIS MALFUNCTION OCCURRED AFTER THE DEVICE WAS FILLED WITH FLUOROURACIL, BEFORE IT WAS CONNECTED TO THE PATIENT. THERE WAS NO REPORT OF ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273178 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A006

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL