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

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the washer and found it to be not operational.The user facility was provided with a replacement unit.The unit subject of the event has been returned to steris for evaluation.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that their v-pro max sterilizer caught fire.The floor was evacuated, and the fire department was dispatched.The fire department extinguished the flames.No report of injury.The user facility reported procedure delays 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 as the tube fittings were not properly tightened into the tee.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 2014 and is under steris service agreement for maintenance activities.The last preventive maintenance was completed on february 23, 2021; 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: 11702385
• MDR Text Key: 249078201
• Report Number: 3005899764-2021-00016
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1