MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-03 for V-PRO MAX STERILIZER manufactured by Steris Mexico, S. De R.l. De C.v..
[178313758]
A steris service technician arrived onsite to inspect the sterilizer. Through discussion with facility personnel, the technician learned that after a completed cycle, an employee opened the door of the sterilizer. The operator did not identify any issues and left the room. About 1-2 minutes later, a different employee entered the room and identified the smoke and flames inside the chamber as stated in the reported event. Upon further inspection, the technician identified that something within the chamber that had just been processed caught fire. The technician inspected the sterilizer and found no issue with the function or operation of the sterilizer. The technician confirmed the fire was contained within the chamber. No repairs were required, and the unit was returned to service. The conditions of the reported event are currently under evaluation; a follow-up mdr will be submitted as additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[178313759]
The user facility reported smoke and flames observed from inside the chamber of their v-pro max sterilizer. User facility personnel utilized a fire extinguisher to extinguish the flames. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[183516258]
Based on the technician's inspection and the conditions of the reported event, the root cause of the reported event is attributed to user facility personnel attempting to process materials that were not compatible with vaprox hc sterilant. The v-pro max operator manual states (1-1), "danger - fire and explosion hazard: verify all materials coming in contact with hydrogen peroxide are compatible with oxidizers. Contact steris or the material manufacturer for information on material compatibility. " additionally, the operator manual (a-4 to a-5) provides a list of materials that are and are not compatible with vaprox sterilant. The operator manual further states (3-2), "pre-operation checklist: read all dangers, warning, and cautions in section 1 of this manual before operating the equipment. Then complete the following checklist... Items for sterilization are compatible with vaprox hc sterilant. " a steris account manager performed in-service training with user facility personnel on the proper use and operation of the v-pro max sterilizer, specifically to ensure materials are compatible with the sterilizer prior to use. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005899764-2020-00001 |
| MDR Report Key | 9548663 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2019-12-06 |
| Date Added to Maude | 2020-01-03 |
| 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 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Street | AVENIDA AVANTE 790 PARQUE INDUSTRIAL GUADALUPE |
| Manufacturer City | GUADALUPE, 67190 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 67190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V-PRO MAX STERILIZER |
| Generic Name | STERILIZER |
| Product Code | MLR |
| Date Received | 2020-01-03 |
| 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, 67190 MX 67190 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |