MAUDE MDR 2805472

MDR report key
2805472
Report number
3003900188-2008-00043
Event key
0
Event type
3
Date received
2008-09-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
575 MOUNTAIN AVENUE MURAY HILL NJ 07974 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGENNONELINDE GAS NORTH AMERICA LLCECX07102042657674Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-09-220

Event Narratives#

D

Patient 1

ON (B)(4) 2008, LINDE INITIALLY RECEIVED A REPORT CONCERNING AN INCIDENT HAPPENING ON THE SAME DAY AT A DOCTORS POST IN (B)(6). THE INCIDENT OCCURRED DURING A DEMONSTRATION OF THE USE OF A CONOXIA 2 LITER LIV CYLINDER IN AN OUTSIDE LOCATION. AFTER OPENING THE MAIN VALVE OF THE CYLINDER AND SETTING THE FLOW-REGULATOR TO 25 L/MIN A SISSING NOISE WAS HEARD FOLLOWED BY A BANG AND A FLASH. FLAMES CAME OUT OF THE VALVE PROTECTION, THE MEDIC THREW THE CYLINDER CLEAR AND THE FIRE EXTINGUISHED IMMEDIATELY. THERE WAS LIGHT SOOT FOUND ON THE PRESSURE INDICATOR, ON VALVE PROTECTION NEAR QUICK CONNECTOR AND INSIDE VALVE BEHIND THE CONNECTOR. THERE WERE NO INJURIES AS A RESULT OF THE IGNITION.

N

Patient 1

THE PRESENT CASE IS ONE OUT OF 9 INCIDENT REPORTS IN CONNECTION WITH 7B 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 VALVE) OF THE GCE LIV VALVE 5 MICRON FILTER IS LIKELY TO CAUSE MORE SENSITIVITY TO ADIABATIC COMPRESSION HEATING THAN THE GCE OXYGEN DESIGN.