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

Model Number V-PRO maX

Device Problems Fluid/Blood Leak (1250); Insufficient Information (3190)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and found it to be not operational.The damage was contained within the footprint of the unit.Prior to the reported event, the unit had alarmed "chamber overtemp".The user facility was provided with a loaner unit.Steris has requested the unit subject of the event be returned for evaluation; we are pending release of the unit by the customer.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.No report of injury.

Manufacturer Narrative

The v-pro max sterilizer subject of the event was returned to steris for evaluation.The evaluation found that the tee underneath the reservoir was leaking sterilant.The sterilant leaked onto the sterilizer's components 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 2018 and is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.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
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 12369796
• MDR Text Key: 268210655
• Report Number: 3005899764-2021-00047
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 00724995206987
• UDI-Public: 00724995206987
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V-PRO maX
• Device Catalogue Number: VP30002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1