BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 2303757 · Received July 1, 2011

    Report

    Report Number
    1450997-2011-00002
    Event Type
    Other
    Date Received
    July 1, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 30, 2011
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    FCX
    PMA / PMN Number
    K921088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LABELING INCLUDES NUMEROUS "WARNINGS" AND "CAUTIONS" FOR TUBING SET SETUP, PROPER CONNECTION OF TUBING SET, AND GENERAL MACHINE INSTRUCTIONS. NORTHGATE TECHNOLOGIES INC. STRONGLY FEELS THAT HIS ADVERSE EVENT WAS CAUSED BY HUMAN ERROR AND IT IS NOT A MALFUNCTION OF OUR DEVICE, THE SP-2 PUMP, AND/OR THE TUBING SET, (B)(4).

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE USING THE OLYMPUS SP-2 IRRIGATOR AND EVACUATION DEVICE. THE DEVICE OPERATES BY USE OF A ROLLER PUMP HEAD. A NURSE SETTING UP THE DEVICE MISTAKENLY INSERTED THE TUBING BACKWARDS IN THE ROLLER HEAD. THIS RESULTED IN THE DEVICE INSUFFLATING THE BLADDER AT BETWEEN 1 AND 1.5 LITERS PER MINUTE OF AIR FOR APPROX 5-10 MINUTES BEFORE THE ISSUE WAS IDENTIFIED. THE PT DEVELOPED HYPOTENSION, EXTENSIVE SQ EMPHYSEMA AND PNEUMOTHORAX. THE PT REQUIRED FURTHER MONITORING AND CHEST TUBE PLACEMENT, SUBSEQUENTLY, THE CHEST TUBE WAS REMOVED, AND THE PT RETURNED TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NONE FCX NORTHGATE TECHNOLOGIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization