MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-03-01 for EAGLE 3017 EO STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[2525008]
Two steris service technicians and one user facility employee were potentially exposed to a low concentration of ethylene oxide gas while performing maintenance on an eagle 3017 eo sterilizer. A strong odor was noted and the area eo monitor alarmed when the sterilizer door was opened. The three persons present at the time evacuated the immediate area per the facility procedures. No injuries were reported and no immediate medical treatment was received. There were no reported procedural delays or cancellations.
Patient Sequence No: 1, Text Type: D, B5
[9655325]
Two steris service technicians were servicing the eo sterilizer. The technicians were calibrating the puncture cylinder mechanism while an eo canister was loaded in the sterilizer. The technicians proceeded with troubleshooting, brought the sterilizer chamber down to atmospheric pressure several times, and opened the chamber door. The facility eo monitor located in the vicinity of the sterilizer alarmed, indicating the presence of eo in the area. It is believed that while there was not sufficient gas in the chamber to raise the chamber pressure above atmospheric pressure, sufficient residual gas was present to set off the facility eo alarm. The hospital reported its employee's eo monitor showed no detectable eo and thus no additional medical evaluation is required. One steris service technician was examined shortly after the incident and the doctor stated that the short duration exposure to a low eo concentration was not a concern; the second technician is scheduled for a medical exam on (b)(6) 2012 to confirm that there were no adverse effects. The sterilizer is covered by steris maintenance contract and the prior preventive maintenance was performed on 1/31/2012 when the equipment was found to be operating properly. The practice used by the two steris service technicians was contrary to the procedures specified in the maintenance manual, which states: "danger: eo exposure/personal injury hazard: do not use any eo cartridge during the puncture cylinder procedure. " maintenance manual, sec. 6. 12. 10, p. 6-13. The service technicians involved in this event, as well as all service technicians within the service region, have been retrained on the proper method of performing the puncture cylinder procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2012-00011 |
| MDR Report Key | 2475027 |
| Report Source | 06,07 |
| Date Received | 2012-03-01 |
| Date of Report | 2012-03-01 |
| Date of Event | 2012-02-01 |
| Date Mfgr Received | 2012-02-01 |
| Date Added to Maude | 2012-03-02 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE 3017 EO STERILIZER |
| Generic Name | EO STERILIZER |
| Product Code | FLF |
| Date Received | 2012-03-01 |
| 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 | 2012-03-01 |