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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 03/06/2014

Event Type  Injury  

Event Description

The user facility reported two employees received chemical burns from residue on a peel pouch while unloading items from the v-pro max sterilizer.The employees were sent to the emergency room where one person was treated with a cream.The other employee was not treated.Both employees have returned to full work duties.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, evaluated the v-pro max sterilizer and found the equipment operating to specification.No repairs were required; the reported event could not be duplicated.The steris technician confirmed that the employees were not wearing ppe, gloves, at the time of the event.The operator manual (6-11) states, "unload sterilization unit: steris recommends (in accordance with ansi/aami st58, 2005) wearing chemical -resistant gloves when using the sterilization unit.In addition, the operator manual (1-2) states, "danger - chemical injury hazard: any visible liquids in the chamber must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions." a steris account manager and clinical education specialist in-serviced the facility on the importance of wearing ppe and drying instruments completely before being placed in the v-pro max sterilizer.No further 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, 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: 3722267
• MDR Text Key: 4306092
• Report Number: 3005899764-2014-00022
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 04/02/2014
• 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