MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO 1 PLUS STERILIZER

Device Problem Insufficient Information (3190)

Patient Problem Irritation (1941)

Event Date 07/28/2014

Event Type  No Answer Provided  

Event Description

The user facility reported employees are experiencing irritation when using the v-pro 1 plus sterilizer.

Manufacturer Narrative

The facility stated 11 of the 25 staff members have been exposed to hydrogen peroxide from the v-pro 1 unit and experience irritation around the throat, eyes and nose.One employee sought and received medical treatment at the facility's emergency room after experiencing eye irritation.Following notification of the event, steris personnel from field service and engineering arrived at the facility and evaluated the unit.The evaluation concluded the v-pro 1 plus sterilizer is performing to specification.The unit successfully passed two pressure verification tests and a leak test.Additional test cycles were performed to simulate lumen and non lumen cycle runs.These test cycles successfully completed without alarms or cycle aborts.The room in which the v-pro 1 plus unit is located is not supplied with sufficient air exchanges per hour per aami st58:2013.On (b)(4) 2014, a conference call was held between steris personnel (product management, service engineering and r&d) and a representative from the user facility.During the call, the facility committed to addressing the aami standard for air exchanges per hour.

• Brand Name: V-PRO 1 PLUS STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4042489
• MDR Text Key: 4805939
• Report Number: 3005899764-2014-00071
• Device Sequence Number: 1
• Product Code: MLR
• 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
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other