MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-09-22 for GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN 0710204 manufactured by Linde Gas North America Llc.
[2943438]
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.
Patient Sequence No: 1, Text Type: D, B5
[10252072]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2009-00061 |
| MDR Report Key | 2805473 |
| Report Source | 01,05 |
| Date Received | 2008-09-22 |
| Date Mfgr Received | 2009-12-09 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2012-11-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 575 MOUNTAIN AVENUE |
| Manufacturer City | MURRAY HILL NJ 07974 |
| Manufacturer Country | US |
| Manufacturer Postal | 07974 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2008-09-22 |
| Model Number | 0710204 |
| Lot Number | 4248769 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINDE GAS NORTH AMERICA LLC |
| Manufacturer Address | MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-22 |