BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2805473 · Received September 22, 2008

    Report

    Report Number
    3003900188-2009-00061
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Product Code
    ECX
    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. EVALUATION 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 MANUFACTURING 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 MANUFACTURING 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) 2009, LINDE RECEIVED A NOTIFICATION THAT AN IGNITION OF A MEDICAL OXYGEN CYLINDER HAD OCCURRED AT (B)(6) MEDICAL CENTRE (B)(6), ON (B)(6) 2009 AFTER SURGERY, THE UNCONSCIOUS PATIENT WAS MOVED FROM THE OPERATING TABLE ONTO A BED SO THE PATIENT COULD BE TRANSPORTED TO THE RECOVERY ROOM. THE PATIENT WAS STILL CONNECTED TO THE OXYGEN FROM THE ANAESTHESIOLOGY EQUIPMENT, WHILE THE ANAESTHETIST WAS BUSY TO CONNECT THE PATIENT TO MEDICAL OXYGEN FROM AN UNUSED (=FULL) 2 LITERS ALU CYLINDER WITH A GCE LIV VALVE. THE CYLINDER WAS HANGING VERTICALLY ON THE HEAD SIDE OF THE BED WHEN THE ANAESTHETIST SET THE FLOW REGULATOR TO 10L/MIN. THE MAIN SOV WAS OPENED FOLLOWED IMMEDIATELY BY A HISSING SOUND AND A LOUD BANG. RIGHT AFTER THE BANG, RED FLAMES OF A FEW METERS EJECTED FROM THE VALVE/REGULATORY BODY. THE FLAMES WERE INITIALLY SMOTHERED WITH A PILLOW AND A FEW SECONDS LATER A COLLEAGUE RUSHED IN FROM THE HALLWAY AND EXTINGUISHED THE FIRE WITH CARBON DIOXIDE FIRE EXTINGUISHER. THERE WAS NO HARM TO ANY PERSON.

    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 4248769

    Patients

    Seq Age Sex Outcome Treatment
    1