MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-13 for SYSTEM 1E PROCESSOR manufactured by Steris Canada Corporation.
[183084982]
The event occurred during a diagnostic cycle; no instruments were present in the system 1e processor. A steris service technician arrived onsite to inspect the system 1e processor and found the unit to be operating according to specifications. No repairs were required. Upon further discussion with the user facility, the technician learned that during the time of the reported event, the user closed the unit's lid with the aspirator probe assembly not properly seated, which allowed water and some residual s40 sterilant to leak out of the unit and onto the floor. While cleaning up the leak, the employees utilized a cleaning agent that is a strong oxidant, which is not compatible with the s40 sterilant, causing the employees to experience eye and chest irritation. The s40 sterilant safety data sheet states, "stability and reactivity: incompatible materials - oxidizers". The safety data sheet for the facility's cleaning agent (defender) states, "contact with acids releases toxic gases". The technician counseled the user facility on proper use and operation of the system 1e processor, specifically, assuring the aspirator probe assembly is properly seated prior to initiating a cycle, and the importance of not mixing incompatible agents. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[183084983]
The user facility reported that three employees experienced eye and chest irritation while cleaning up water that leaked from their system 1e processor. Medical treatment was sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2020-00004 |
| MDR Report Key | 9707835 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 1E PROCESSOR |
| Generic Name | SYSTEM 1E PROCESSOR |
| Product Code | MED |
| Date Received | 2020-02-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |