MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-01-06 for 3017 ETO STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[1724157]
The user facility reported that an employee opened the sterilizer's chamber door following an aborted processing cycle and a "strong gas" smell was noted. The cycle was aborted during the aeration phase to allow for ethylene oxide measurements to be taken by a third party that was on-site at the time of the reported event. The cycle was aborted approximately two hours into a minimum aeration cycle of 12 hours.
Patient Sequence No: 1, Text Type: D, B5
[8863217]
The facility declined an offer for in-service training.
Patient Sequence No: 1, Text Type: N, H10
[8945120]
A steris service technician inspected the sterilizer, ran several cycles and found the unit to be operating properly. The technician also verified that the unit had no internal leaks, the door seal was functioning properly and that no alarms were noted during the processing cycle that was aborted by the facility employee. All functional checks evidenced passing results. The technician did note that the vent line in the ceiling above the sterilizer was detached, which allowed residual ethylene oxide gas and water vapor from the abator to be exhausted into the ceiling above the unit rather than outside the building as intended. User facility maintenance personnel re-attached the vent line. No further issues have been reported with the equipment. The equipment operator manual states (pp. 6-14): "pausing aeration procedure - wait at least 15 minutes with door cracked open before fully opening chamber door. The operator and other personnel nearby must leave the immediate area around the sterilizer during this period. " the cause of the reported "strong gas "smell appears to be attributed to (1) the user facility employee not following the proper procedure for pausing an aeration cycle, and (2) the detached facility vent line which allowed residual ethylene oxide to be exhausted into the ceiling area above the sterilizer. Steris offered to conduct in-service training regarding the proper use and operation of the sterilizer and is awaiting a response.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2011-00001 |
| MDR Report Key | 1951377 |
| Report Source | 06 |
| Date Received | 2011-01-06 |
| Date of Report | 2011-01-06 |
| Date of Event | 2010-12-14 |
| Date Mfgr Received | 2010-12-14 |
| Date Added to Maude | 2012-04-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| Manufacturer G1 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, NUEVO LEON 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3017 ETO STERILIZER |
| Generic Name | STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLF |
| Date Received | 2011-01-06 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Address | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE GUADALUPE, NUEVO LEON 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-06 |