BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4-WAY STOPCOCK WITH MALE LUER LOCK

    MDR report key: 2080088 · Received April 6, 2011

    Report

    Report Number
    1625425-2011-00040
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    October 6, 2010
    Report Date
    April 6, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    DTL
    PMA / PMN Number
    K780271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LAPAROSCOPIC COLONIC SURGERY UNDER TIVA (TOTAL INTRAVENOUS ANESTHESIA). AS PER ROUTINE, BOTH ARMS WERE TACKED AT PT SIDE, SO IV INSERTION SITE AND STOPCOCK ARE NOT VISIBLE. UNEVENTFUL MANAGEMENT FOR 3 HOURS, NO HEMODYNAMIC CHANGES UNTIL THE PT MOVES ON THE OPERATING TABLE (PT NOT UNDER MUSCLE RELAXANT EFFECTS AS PER ROUTINE). PROPOFOL SPILL WAS NOTICED ON THE FLOOR. IMMEDIATELY VOLATILE AGENTS WERE INITIATED. THE STOPCOCK CONNECTED TO PROPOFOL WAS LEAKING AND PROBABLY HALF OF THE DOSE WAS STILL BEING INFUSED TO THE PT, AND HALF ACTUALLY LEAKING THROUGH CENTER OF THE ROTATING DEVICE. NEXT TO THIS DEFECTIVE STOPCOCK WAS A SIMILAR 4-WAY STOPCOCK INFUSING REMIFENTANIL, WHICH WAS WORKING PROPERLY AND NO LEAKING AT ALL. IN THE POSTOPERATIVE PERIOD (POSTOPERATIVE CARE UNIT AND WARDS) PT RECALLED THE EPISODE OF MOVING AND BEING BOTH HANDS TACKED, AND EYES TAPED. IT WAS AN ACTUAL SHORT PERIOD OF INTRAOPERATIVE ANESTHESIA AWARENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4-WAY STOPCOCK WITH MALE LUER LOCK DTL ARGON MEDICAL DEVICES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other PROPOFOL