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

Device Problem Break (1069)

Patient Problem Chemical Exposure (2570)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the v-pro max sterilizer, however, the facility was unable to identify which of the two units on site was subject of the reported event.The steris service technician confirmed all units were found to be operating properly.No issues with the function or operation of the sterilizers were identified.Based on the description of the event, the bi must have been damaged prior to the cycle.The employee subject of the event was not wearing proper ppe, specifically gloves as stated in the operator manual.The operator manual states (pp.6-14), "ansi/aami st58, 2013, recommends using chemical-resistant gloves when using the sterilization unit".The v-pro max sterilizer operator manual (1-2) states, "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions.When handling hydrogen peroxide, wear appropriate personal protective equipment".The account manager counseled facility personnel on the importance of wearing proper ppe, specifically gloves while operating their v-pro max sterilizer as well as thoroughly inspecting bi's for damage prior to use.No additional issues have been reported.

Event Description

The user facility reported that an employee experienced discoloration on their hands after removing a broken steris hp self-contained biological indicator from a v-pro max sterilizer following a completed sterilization cycle.The bi was broken which allowed hydrogen peroxide to become trapped and remain after the cycle, resulting in the reported event.The employee sought medical treatment and received bandages.

• 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: 8693427
• MDR Text Key: 148160460
• Report Number: 3005899764-2019-00059
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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: 05/15/2019
• 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