BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMVEX FLOWMETER

    MDR report key: 7263180 · Received February 9, 2018

    Report

    Report Number
    7263180
    Event Type
    Death
    Date Received
    February 9, 2018
    Date of Event
    January 29, 2018
    Report Date
    February 2, 2018
    Manufacturer
    OHIO MEDICAL
    Product Code
    CCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPICE PATIENT WAS PLACED ON 70 PERCENT FIO2 VIA T-PIECE DELIVERED AT 15 L/MIN. OXYGEN TUBING WAS WITNESSED BY NURSING STAFF TO POP OFF AT VENTURI CONNECTION. THIS WAS REPLACED BY STAFF. PATIENT WAS FOUND WITH T-PIECE ON CHEST AND O2 DISCONNECTED FROM FLOW METER. INDICATOR BALL NOTED TO BE FLOATING AT TOP OF METER. PATIENT EXPIRED. NURSE, UPON FINDING PATIENT, RECONNECTED OXYGEN AND DURING ASSESSMENT OF PATIENT FOR ANY VITAL SIGNS, TUBING AGAIN DISLODGED FROM FLOW METER. FLOW METER WAS TESTED BY BIOMEDICAL DEPARTMENT AND FOUND IT TO BE DELIVERING OXYGEN OUTSIDE OF MANUFACTURER SPECIFICATION. AT 15 L, THE FLOW METER WAS DELIVERING 20.14 L/MIN. UTILIZING A DIFFERENT OXYGEN SET UP MIRRORING THE PATIENT SET UP IN A CONTROLLED BIOMED ENVIRONMENT, TUBING CONNECTED TO THIS FLOW METER AGAIN POPPED OFF AT THE VENTURI CONNECTION AT 10 MINUTES OF FLOW, AND ONCE REPLACED, REGULATOR BALL WAS WITNESSED TO DRIFT TO THE TOP OF REGULATOR. ONCE TUBING REPLACED, THE SYSTEM POPPED OFF THE TUBING AGAIN AT 20 MINUTES OF FLOW. REF MFR # 1419185-2018-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101889 AMVEX FLOWMETER AMVEX FLOWMETER CCN OHIO MEDICAL FMAC 2946960

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death