BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2781236 · Received October 10, 2012

    Report

    Report Number
    1416980-2012-02017
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS PENDING RECEIPT OF THE SAMPLE. UPON COMPLETION OF THE EVALUATION, OR SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION WAS NOT CONFIRMED, AS NO LEAKS WERE OBSERVED. THE SAMPLE WAS PUT THROUGH WATER PRESSURE AND SEPARATION TESTING, WHICH THE SAMPLE PASSED WITH NO OBSERVED FAILURES. THEREFORE, NO ROOT CAUSE COULD BE IDENTIFIED. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF ONE 4-WAY LARGE BORE (LIPID RESISTANT) STOPCOCK THAT WAS ALLEGED TO BE LEAKING WHEN CONNECTED TO A MICROCLAVE CONNECTOR, PRODUCT CODE "MC100", MANUFACTURED BY ICU MEDICAL, INC. THIS LEAK WAS OBSERVED DURING INFUSION ON AN UNKNOWN PATIENT. THE AFFECTED PRODUCTS WERE SWAPPED OUT FOR UNKNOWN PRODUCTS, AND THERAPY WAS CONCLUDED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR10K02051

    Patients

    Seq Age Sex Outcome Treatment
    1