BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3153465 · Received June 8, 2013

    Report

    Report Number
    1416980-2013-14616
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. TO VERIFY THE REPORTED CONDITION, THE FILL PORT CAP WAS REMOVED. UPON REMOVAL, A RAPID BACK-FLOW (LEAK) WAS OBSERVED AT THE FILL PORT. VISUAL EXAMINATION OF THE DEVICE REVEALED THE CAUSE OF THE LEAK WAS A 1.3-MM DARK GRAY PARTICLE CONSISTENT WITH RUBBER USED FOR DRUG VIAL SEPTA TRAPPED BETWEEN THE CHECK BAND AND THE STRESS MEMBER. THIS MATERIAL IS NOT PRESENT AT THE MANUFACTURING PLANT; THEREFORE, THE CAUSE WAS DETERMINED TO BE HUMAN FACTORS. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE HAS BEEN RECEIVED FOR EVALUATION. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR LEAKED. THE NURSE HAD FILLED THE DEVICE WITH ABOUT 40 ML OF 5FU WHEN THE DEVICE STARTED TO LEAK FROM THE "POINT OF FILLING". THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257187 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N058

    Patients

    Seq Age Sex Outcome Treatment
    1