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 Burn(s) (1757)

Event Date 02/13/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee was burned while removing items from the v-pro max sterilizer.The employee visited employee health, was treated for a chemical burn and was cleared to return to work.No procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, inspected the v-pro max sterilizer and confirmed the unit was operating to specification.No repairs to the v-pro max sterilizer were required; the reported event could not be duplicated.The steris technician determined that the steris scbi present in the cycle had been damaged at some point during processing.The verify scbi instructions for use contain the following caution: "caution: in some instances residual hydrogen peroxide may be trapped within the media of a damaged scbi.Should this occur avoid direct contact with the scbi and its contents.Place entire test pouch and its contents into a steam compatible container and dispose according to the instructions at the end of this document." steris conducted retain testing on the biological indicator lot subject of the reported event.The retain samples were placed in the v-pro sterilizer, and upon completion of the cycle the samples were removed and inspected for any evidence of broken ampoules and/or leaking media.All ampoules were intact after exposure and exhibited no evidence of leakage.The employee subject of the reported event was not wearing the appropriate ppe as recommended in the v-pro max operator manual.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." the account manager for the facility confirmed that additional in-service training was provided on (b)(4) 2014.

• 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: 3678883
• MDR Text Key: 16686767
• Report Number: 3005899764-2014-00017
• 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: 03/14/2014

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: 02/13/2014
• Initial Date FDA Received: 03/14/2014
• 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