BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN

    MDR report key: 2805401 · Received September 17, 2010

    Report

    Report Number
    3003900188-2010-00039
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    November 23, 2008
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENT CASE IS ONE OUT OF 9 INCIDENT REPORTS IN CONNECTION WITH 7 LIV IGNITIONS. EVAL SUMMARY: ROOT CAUSE ANALYSIS SUMMARY - THE CAUSE OF IGNITION WITH HIGHEST PROBABILITY IS IGNITION OF HYDROCARBONS, LUBRICANT, AND/OR DEBRIS BY ADIABATIC COMPRESSION. POTENTIAL SOURCES OF HYDROCARBONS AND LUBRICANTS; LUBRICANT (FOMBLIN) MIGRATION (LUBRICANT FROM GCE MFG OF VALVE), LEACHING OF CONTAMINANTS (PHTHALATES) FROM O-RINGS IN VALVES (LUBRICANT IN SOLVENT) AND HYDROCARBON OIL, LEACHING OF CONTAMINANTS (PHTHALATES) FROM FILL CONNECTOR AT FILLING PLANT AT LINDE. POTENTIAL SOURCES OF DEBRIS - DEBRIS FROM MFG PROCESS OF VALVE AT GCE, DEBRIS FROM FILLING PLANT AT LINDE, DEBRIS FROM WEAR, VALVES IN USE. THE DESIGN (FILTER AND LOCATION OF COMPONENTS IN THE HIGH PRESSURE SIDE OF THE VALVE) OF THE GCE LIV VALVE 5 MICRON FILTER IS LIKELY TO CAUSE MORE SENSITIVITY TO ADIABATIC COMPRESSION HEATING THAN THE GCE OXYGEN DESIGN.

    Description of Event or Problem · 1

    ON (B)(6) 2008, LINDE WAS NOTIFIED OF AN INCIDENT IN CONNECTION WITH THE USE OF A LINDE INTEGRATED VALVE. ON (B)(6) 2008, ON ARRIVAL OF A PT AT (B)(6), THE ASSISTANT ANAESTHESIST WAS PREPARING TO GIVE THE PT MEDICINAL OXYGEN. THE LIV 2 L CYLINDER WAS MOUNTED ON THE HEAD OUTSIDE THE BED (VERTICAL POSITION). THE ASSISTANT ANAESTHESIST OPENED FIRST THE FLOW-REGULATOR TO 15 L/MIN AND OPENED THEN THE MAIN VALVE. WHILE CONNECTING THE HOSE/TUBE TO THE NIPPLE, AN AUDIBLE HISSING SOUND WAS HEARD INSIDE THE CAP, FOLLOWED BY A FLAME. ALL PERSONNEL PRESENT FLED FROM THE AREA AND THE CYLINDER FELL ON THE GROUND. SHORTLY AFTER THAT, A FLAME CAME OUT OF THE VALVE, WHICH EXTINGUISHED AFTER A SHORT TIME. THE FIRE-ALARM WAS ACTIVATED AND THE FIRE BRIGADE ARRIVED 8 MINUTES LATER. THERE WAS SOOT AT THE BEGINNING OF THE HOSE, THE MASK WAS CLEAN. DURING THE INCIDENT, THE PT WAS UNCONSCIOUS. THE ASSISTANT ANAESTHESIST SUFFERED OF SECOND DEGREE BURNS (RECUPERATABLE) ON HIS HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN NONE ECX LINDE GAS NORTH AMERICA LLC 0710204 2551101

    Patients

    Seq Age Sex Outcome Treatment
    1