BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 278375 · Received May 19, 2000

    Report

    Report Number
    278375
    Event Type
    Death
    Date Received
    May 19, 2000
    Date of Event
    May 11, 2000
    Report Date
    May 15, 2000
    Manufacturer
    ALLIED HEALTHCARE PROD.
    Product Code
    CAN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INTUBATED PT WAS INADVERTENTLY CONNECTED TO THE UNREGULATED OUTPUT OF AN OXYGEN REGULATOR ON A SMALL OXYGEN BOTTLE VIA A JACKSON-REESE TUBING SET. THE PT WAS SUPPOSED TO BE CONNECTED TO THE REGULATED (0-25LPM) OUTPUT. REGULATOR HAD SIMILAR THREADED CONNECTORS FOR BOTH THE REGULATED AND UNREGULATED OUTPUTS. BECAUSE THE OXYGEN FLOW OUT OF THE UNREGULATED CONNECTOR GREATLY EXCEEDED 25LPM, THE PT SUFFERED A PNEUMOTHORAX AS A RESULT. THE INCIDENT REVEALED THAT ANY REGULATOR HAVING INTERCHANGEABLE OUTPUT CONNECTORS FOR BOTH REGULATED (UP TO 25LPM) AND UNREGULATED (50PSI) OUTPUTS CREATES AN UNACCEPTABLE RISK OF THE WRONG CONNECTOR BEING USED. THE REGULATOR IN THIS INCIDENT HAD A DISS MALE REGULATED OUTLET AND A DISS CHECK VALVE FOR THIS UNREGULATED OUTPUT. THE DISS FITTING FOR THE REGULATED OUTPUT WAS MISSING, WHICH CONTRIBUTED TO THE USER INADVERTENTLY CONNECTING THE THERAPEUTIC TUBING ONTO THE UNREGULATED CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * OXYGEN REGULATOR CAN ALLIED HEALTHCARE PROD. AHP 32-29-5204 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death