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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician was onsite performing a service activity on a different unit and was notified of the smoke by user facility personnel.The technician opened the lower compartment of the unit subject of the event and observed flames inside the unit.The flames were extinguished by user facility personnel with a fire extinguisher.The unit was removed from service.Steris is awaiting a response from the customer regarding release of the unit.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that their v-pro max sterilizer was emitting smoke.The floor was evacuated, and the fire department was dispatched.No report of injury.The user facility reported procedure postponements due to the reported event.

Manufacturer Narrative

The v-pro max sterilizer subject of the event was returned to steris for evaluation.The evaluation found that the tee that connects sv5 and sv4 underneath the reservoir was leaking sterilant.The sterilant leaked onto components within sterilizer resulting in the reported event.The tee should be replaced annually in accordance with the v-pro max sterilizer preventive maintenance checklist.The unit was installed in 2017 and is under steris service agreement for maintenance activities.The last preventive maintenance was completed in (b)(6) 2020; the tee was replaced at this time and the unit was confirmed to be operating according to specifications.The user facility was provided with a replacement unit.No additional issues have been 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: 11164009
• MDR Text Key: 227926769
• Report Number: 3005899764-2021-00001
• 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
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1