BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR SV 4ML/H

    MDR report key: 2003402 · Received March 1, 2011

    Report

    Report Number
    6000001-2011-01443
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    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). DEVICE EVALUATION: ONE UNIT WAS RECEIVED BY BAXTER FOR EVALUATION CONTAINING NO FLUID IN THE BLADDER. EVIDENCE OF FLUID WAS NOTED IN THE SEALED BAG THAT ENCLOSED THE SAMPLE, HOWEVER AFTER PERFORMING A LEAK TEST ON THE SAMPLE, NO SIGNS OF LEAK WERE OBSERVED ON THE SAMPLE. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) FOLFUSOR SV DEVICE WAS OBSERVED LEAKING AFTER FILLING WITH 5-FLUOROURACIL. THERE WAS NO PATIENT INVOLVEMENT; THE LEAK WAS OBSERVED BEFORE PATIENT CONNECTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR SV 4ML/H PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H003

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL