MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-12 for 3017 EO GAS STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[4457696]
The user facility reported their eo monitor system activated, alerting the sterile processing department of a potential eo gas leak. The fire department and hazmat team were dispatched to the facility in response to the alarm. The facility's department was evacuated for over an hour due to the alarm and potential leak. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[11971999]
The facility stated the leak was coming from one or several eto canisters located in the sterile processing room which had been damaged during transport from the facility's receiving department. The facility informed the steris technician that upon receipt of the eto canisters, the facility's receiving department tosses the canisters into a plastic bin to be transported to a fire proof containment box in the facility's spd department. The fire department and hazmat team arrived at the facility and moved all of the eto canisters from the facility's storage cabinet into an empty 3017 eo gas sterilizer and locked the sterilizer door. A steris service technician arrived at the facility and placed the sterilizer into service mode to allow any leaking canister to slowly aerate over a period of several days. Using appropriate ppe, the steris technician then returned to the facility, removed the canisters from the sterilizer and identified a single canister with a very small dent in its cap. The technician used an eo monitor and confirmed the canister was leaking eo gas. All other canisters were inspected and no signs of damage or leaks were identified. The technician placed the damaged canister into the eo sterilizer, ran a normal cycle and ensured the canister was emptied of all eto and properly aerated. The steris technician confirmed that following the event, the facility has modified the way the canisters are handled once received in house to prevent any further eto canister leaks. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2014-00039 |
| MDR Report Key | 3869715 |
| Report Source | 06 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-06-12 |
| Date of Event | 2014-05-22 |
| Date Mfgr Received | 2014-05-22 |
| Date Added to Maude | 2014-06-12 |
| 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 | 3017 EO GAS STERILIZER |
| Generic Name | STERILIZER |
| Product Code | FLF |
| Date Received | 2014-06-12 |
| 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 | 1. Other | 2014-06-12 |