MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO MAX STERILIZER

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

Steris utilized an independent third-party to perform residual hydrogen peroxide testing in accordance with chinese standard gb/t 32309-2015, hydrogen peroxide low temperature plasma sterilizer.The results confirmed that the levels of residual hydrogen peroxide were below the requirements outlined within gb/t 32309-2015, confirming that the reported event was not caused by the v-pro max sterilizer, but instead by the processing of items by user facility personnel that were not compatible for processing in the v-pro max.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.Steris will continue to monitor for similar incidents.A review of complaints determined this to be an isolated incident.The unit subject of the event has remained in use since the initial event occurred in december 2019, with no additional issues reported.

• Brand Name: V-PRO MAX STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• MDR Report Key: 9548663
• MDR Text Key: 178313758
• Report Number: 3005899764-2020-00001
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1