MAUDE Adverse Event Report: STERIS CANADA CORPORATION SYSTEM 1 EXPRESS

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

Patient Problem Irritation (1941)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

A steris account manager arrived onsite following the reported event and learned from facility personnel that the employee had inserted the s40 sterilant cup into the unit with excessive force and then proceeded to twist the cup with the aspirator probe already inserted.This sequence caused the lid to rip allowing peracetic acid fumes to escape and the reported event to occur.The s40 cup compartment of the system 1 express is designed so that a cup of s40 can only be properly inserted in one direction.The proper placement of the s40 into the cup compartment aligns with the shape of the cup.The system 1 express operator manual states (3-4), "the container is designed to minimize user contact with the contents.Under normal use conditions, users are not exposed to the liquid contents of the sterilant container.This should not occur if the sterilant container integrity is maintained and the operator manual instructions for handling and inserting the container into the processor are followed." the account manager was able to inspect the s40 cup subject of the event as it had been retained by the user facility.Examination of the sterilant cup confirmed that excessive force had been applied to the cup.The reported event is attributed to user error as the employee should not have inserted the cup into the compartment with excessive force or twisted the cup after placement in the system 1 express.The system 1 express operator manual states (7-2), "step 2 add s40 sterilant concentrare with the palm of one gloved hand resting on the sterilant container, gently push down on the container using firm, even pressure until it is seated and its top is flush with the tray.To avoid damaging the container, never slam the container into the sterilant compartment.Step 3 insert aspirator probe insert the probe in a downward motion until the top of the aspirator is resting on the lid of the container.Step 4 close lid." the operator manual further states (1-3), "cautions: do not push the container into the sterilant compartment with excessive force.Never slam the container into the sterilant compartment.Damage to the container may occur." additionally, the account manager was informed that the employee subject of the reported event was not wearing proper ppe, specifically goggles or face shield, as required when handling s40.The system 1 express operator manual (3-4) states, "caution: 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 procedures." the account manager ran test cycles and found no issue with the function or operation of the system 1 express.No repairs were required, and the unit was returned to service.While onsite, the account manager counseled user facility personnel on the importance of wearing proper ppe, specifically goggles or face shield, as well as the proper procedure for placing a cup of s40 within the system 1 express.No additional issues have been reported.

Event Description

The user facility reported an employee experienced eye and nose irritation while using their system 1 express.The employee rinsed their eyes with water and continued working.

• Brand Name: SYSTEM 1 EXPRESS
• Type of Device: SYSTEM 1 EXPRESS
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9238633
• MDR Text Key: 219781083
• Report Number: 9680353-2019-00037
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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: 09/27/2019
• 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