MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for 3017 ETO STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[63370285]
The user facility stated their 3017 eto sterilizer was failing cycles due to a "failure to hold vacuum" alarm. A steris service technician arrived on-site, opened the sterilizer door to inspect the unit, and identified the eo cartridge was leaking ethylene oxide. This leak was the cause of the "failure to hold vacuum" alarm. When the technician opened the sterilizer to inspect the cartridge, the user facility's eo monitoring system alarmed due to the presence of ethylene oxide and the department was evacuated. The technician placed the eo cartridge back into the sterilizer to contain the leak. In accordance with recommended practices from steris service engineering several cycles were run to dispose of the remaining ethylene oxide. There were no reported injuries as a result of the ethylene oxide leak. When the technician identified the leak, he ran several cycles to empty the eo cartridge. The technician replaced the eo cartridge, tested the unit, and confirmed it to be operating according to specification. The empty eo cartridge is being returned to steris for evaluation. A follow up mdr will be submitted when the investigation is completed. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[63370286]
The user facility reported their 3017 eto sterilizer was failing cycles. No injury, procedure delay, or cancellation was reported.
Patient Sequence No: 1, Text Type: D, B5
[86861385]
During steris' investigation of the reported event, it was determined that the eo cartridge leak was contained within the sterilizer and no eo leaked outside of the unit. The sterilizer operated properly when the eo cartridge leak was detected. An exhaust and air wash sequence in the sterilizer occurred and the chamber door remained locked. When this sequence occurs only a qualified service technician can unlock the chamber door. The steris technician tested the unit and confirmed it to be operating properly. The unit was returned to service and no additional issues have been reported. The eo cartridge subject of the reported event was not returned to steris for evaluation. Investigation with the eo cartridge supplier identified actions to better control variation encountered periodically during cartridge production. After completion of these actions, there have been no further occurrences of cartridge leaks.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2016-00090 |
| MDR Report Key | 6195965 |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2016-12-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| 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 | 3017 ETO STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2016-12-21 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-12-21 |