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

Device Problems Leak/Splash (1354); Device Unsafe to Use in Environment (2918)

Patient Problem Irritation (1941)

Event Date 05/27/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Following the reported leak, the room in which the v-pro max is located was evacuated and cleaned by a third party agency.The employees who experienced the irritation sought treatment at the facility's health department and went home for the remainder of the day.The employees stated they had no lingering effects from the oil leak by the end of the day's events.A steris technician arrived at the facility following the event, inspected the v-pro sterilizer and determined that an o-ring on the filter housing required replacement.The technician replaced the o-ring, ran a test cycle, and confirmed the unit was operating according to specification.As the unit's scheduled maintenance date was approaching, the technician also performed a preventive maintenance on the unit including replacement of the unit's o-rings and completion of an oil change.The technician also inspected the unit's piping assembly, vaporizer assembly, and injection assembly and confirmed that all areas were in proper working condition.No further leaks were observed.The user facility requested additional educational training on the v-pro unit to ensure the hospital staff are familiar with the proper operation of the unit.The facility's steris account manager and clinical education specialist are working with the facility to schedule a time to perform the in-service training.No additional issues have been reported.

Event Description

The user facility reported an oil leak from their v-pro max sterilizer.Employees working in the vicinity of the sterilizer stated they experienced irritation in their eyes and throats due to the leak.

• 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, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5744644
• MDR Text Key: 48967065
• Report Number: 3005899764-2016-00046
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2016
• Initial Date FDA Received: 06/23/2016
• 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