MAUDE Adverse Event Report: STERIS CORPORATION - HOPKINS STERIS SYSTEM 1E; LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Device Problem Human-Device Interface Problem (2949)

Patient Problem Chemical Exposure (2570)

Event Date 03/13/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee came into the contact with liquid when leaning up against the counter in which the system 1e is installed.The employee went to employee health where the affected area was flushed with water.The employee was given a prescription antibiotic and vitamin e capsules.

Manufacturer Narrative

The employee was wearing cotton scrub pants and only gloves.She leaned up again the countertop and felt irritation on her right thigh.Later in the day when the employee was changing clothes she noticed the area had blistered.A steris service technician inspected the system 1e by removing the bottom shroud, initiated a diagnostic cycle and traced a leak to where the thermocouple is installed into high pressure transition block.The rate observed was slow and constant drip.The technician removed tc2, wrapped threads with teflon tape and reinstalled.He ran three diagnostic cycle observed no leak and found the system 1e to be operational.The employee was not wearing an apron as stated in the operator manual.The operator manual states (pp.1-3), "appropriate personal protective equipment (ppe) is required when handling containers of s40 sterilant concentrate.Minimally, ppe should consist of chemical-resistant gloves, apron, goggles or face shield, and any other protection required by facility procedure." the steris account manager will schedule an in-service training on proper use and operation of the system 1e.

Manufacturer Narrative

A steris account manager performed in-service training on the proper use and operation of the device including the importance of reprocessing.

• Brand Name: STERIS SYSTEM 1E
• Type of Device: LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION - HOPKINS; 6515 hopkins road; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3746039
• MDR Text Key: 19761823
• Report Number: 3000251274-2014-00027
• Device Sequence Number: 1
• Product Code: MED
• 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,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• 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: 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