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

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility reported their system 1e processor was not completing cycles due to a concentration monitor cycle fault and then due to a max pure filter cycle fault.The unit was removed from service.A user facility biomed technician inspected the unit, and concluded that the system 1e required repair.The user facility contacted steris to perform an evaluation on the unit due to the reported event.A steris service technician arrived on-site, inspected the unit, and identified that an air and water line were improperly connected to the system 1e processor and the max pure filter housing required replacement.The technician could not duplicate the concentration monitor cycle fault.In medwatch #(b)(6), the user facility reported utilizing a damaged tray with their system 1e processor.Use of a damaged tray can cause the reported concentration monitor cycle fault.While onsite, the steris service technician inspected the user facility system 1e trays and found that all trays were free of damage and were operating properly.The technician replaced the max pure filter housing, properly re-attached the air and water lines, tested the system 1e, and confirmed it to be operating according to specification.The unit was returned to service.The technician determined that the root cause of the reported event was improper maintenance of the unit.The unit is serviced by a third-party maintenance provider.Steris will provide in-service training with the third-party maintenance provider on the proper maintenance practices for the system 1e processor and will recommend the user facility inspect trays for damage prior to use in the system 1e processor.No additional issues have been reported.

Event Description

The user facility reported via med watch #(b)(6) that their system 1e processor was not completing cycles.No injury, procedure delay, or cancellation occurred.

• Brand Name: STERIS SYSTEM 1E
• Type of Device: LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6195914
• MDR Text Key: 63489456
• Report Number: 9680353-2016-00128
• 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
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/21/2016
• 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