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

Device Problems Smoking (1585); Fumes or Vapors (2529)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that their v-pro 1plus sterilizer is producing fumes.In addition, the customer stated the room was full of smoke.The fire department was not dispatched and no evacuations were reported.No injuries or procedural delays or cancellations were reported.

Manufacturer Narrative

A steris service technician inspected the sterilizer and found that the sterilizer was leaning slightly right.Steris engineering stated that the sterilizer being slightly off balance may have led to excessive vibrations while the pump was running causing the filter seal to come loose.The vacuum pump produces oil fumes which if sealed properly will be stopped from escaping through the odor filter.The vacuum pump oil is non-toxic and not considered hazardous; the amount emitted and the frequency at which it occurs is limited.In sensitive individuals short term nuisance effects may occur (i.E.Headache) with no expected long term effects.The technician replaced the filter and leveled the unit and returned it to service.The sterilizer is under steris service contract and received routine preventive maintenance on (b)(4) /2014.

• 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: 4270549
• MDR Text Key: 5228891
• Report Number: 3005899764-2014-00115
• 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: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• 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
• Date Manufacturer Received: 10/22/2014
• 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