MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-09 for EO GAS STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[3635265]
The user facility reported an eto leak. No injuries to hospital staff or patients were reported. The department was evacuated and the fire department was dispatched. No procedural delays or cancellations occurred.
Patient Sequence No: 1, Text Type: D, B5
[10889720]
The user facility's 3rd party technician detached the exhaust manifold assembly from the eo sterilizer while repairing the sterilizer. The exhaust manifold is shared with a second eo sterilizer, and when the second sterilizer was operated, eo gas leaked from the first sterilizer due to disconnection of the exhaust manifold assembly from the first sterilizer. The user facility requested a steris technician to inspect and assess the incident; the steris technician confirmed that the eo sterilizer was correctly installed and operating to steris specifications. When the 3rd party technician removed the exhaust manifold, he did not follow the lock out/tag out safety procedures, resulting in the user facility operating the second eo sterilizer which should not have been operated while the first unit was under maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2013-00081 |
| MDR Report Key | 3274828 |
| Report Source | 06 |
| Date Received | 2013-08-09 |
| Date of Report | 2013-08-09 |
| Date of Event | 2013-07-10 |
| Date Mfgr Received | 2013-07-11 |
| Date Added to Maude | 2013-11-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | EO GAS STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2013-08-09 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-08-09 |