MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-04-13 for EAGLE 3017 100% ETHYLENE OXIDE STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[1298563]
The user facility reported that a hospital employee attempted to unload an ethylene oxide (eo) gas sterilizer that had been labeled as "out of service" following a false alarm that occurred during the aeration cycle. The employee noticed the sign as she touched the metal basket in the sterilizer, at which point she closed the sterilizer and notified the or director. The employee was not wearing personal protective equipment (ppe) as required in the operator manual. At the time of the incident, the employee washed and rinsed her hands and sought treatment at the facility er for chemical exposure. She also went to the facility? S occupational health department for evaluation where she received x-rays. She returned to work the following day. The employee later reported that she is fine and sustained no injury.
Patient Sequence No: 1, Text Type: D, B5
[8532736]
The user facility reported that an eo alarm had gone off the day prior to the event. On that day a steris service technician responded and found that a false alarm had occurred in the back access room of the facility and confirmed through monitor readings that no ethylene oxide was detected in the surrounding area. Per standard procedure, the technician turned the sterilizer off prior to investigating the alarm and placed a sign on the sterilizer stating "out of service". The following day when the hospital employee attempted to unload the sterilizer, she did not immediately notice the "out of service" sign. The hospital employee was not wearing ppe, which is advised in the operator manual on page 6-15, "wear personal protective equipment, including butyl rubber gloves when handling processed items". Steris service technicians evaluated the sterilizer and monitor and again verified that there were no traces of ethylene oxide present in the department and confirmed that the sterilizer was functioning properly. Upon inspection of the monitor they found a clamp on the concentrator was broken, which caused the false alarm. They replaced the clamp and the pump, calibrated the unit and confirmed the monitor was operating properly. A steris service technician was again on-site several days later when the department ran the sterilizer and verified that the unit operated properly and that no alarms occurred during the cycle. The department manager then placed the sterilizer back in service. Steris conducted an in-service training for hospital personnel on the use of ppe and the warnings associated with use of the ethylene oxide sterilizer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2010-00005 |
| MDR Report Key | 1657535 |
| Report Source | 06 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-04-13 |
| Date of Event | 2010-03-21 |
| Date Mfgr Received | 2010-03-21 |
| Date Added to Maude | 2010-04-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE 3017 100% ETHYLENE OXIDE STERILIZER |
| Generic Name | STERILIZER, ETHYLENE-OXIDE GAS |
| Product Code | FLF |
| Date Received | 2010-04-13 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2010-04-13 |