BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2805417 · Received September 17, 2010

    Report

    Report Number
    3003900188-2010-00035
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    May 28, 2010
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    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 (B)(4). 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) 2010, A MALE NURSE ((B)(6) YEARS OF AGE) DELIVERED OXYGEN TO A HOMECARE PT WITH A CHRONIC ASTHMA ATTACK, AND WHEN THE CANNULA WAS PLACED, THERE WAS A FLASH THAT BROKE THE TOMAGOMA OF THE CYLINDER. THE NURSE GOT A FIRST DEGREE BURN IN SIX FINGERS AND WAS OUT OF WORK FOR 10 DAYS. THE NURSE RECOVERED FROM THE BURNS.

    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 0710160 4768666

    Patients

    Seq Age Sex Outcome Treatment
    1