MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2014

Event Type  No Answer Provided  

Event Description

The user facility reported the detergent injection monitoring system is not working properly.

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

A steris service technician arrived onsite, inspected the washer, and identified that the unit was operating properly.The technician found that the detergent monitoring system, which operates independently from the washer, was not properly detecting the amount of detergent injected during a cycle.The technician identified that the washer cycles completed successfully; the washer can be operated without the detergent monitoring system.The steris service technician purged the tubing which delivers detergent to the washer, recalibrated and primed the system.The unit has been returned to service.The vision single chamber washer/disinfector operator manual states (pp.4-39), "good hospital practice dictates all instruments be inspected for visible debris after processing in the reliance vision single-chamber washer/disinfector or in the reliance vision single- chamber large washer/disinfector.Any instrument with visible debris must be rewashed until clean and free of visible debris prior to terminal processing.Failure to reprocess until all visible debris have been removed may impede the terminal processing.".

Event Description

No injuries, procedure delays, or cancellations were caused by the reported event.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4025417
• MDR Text Key: 4806019
• Report Number: 9680353-2014-00062
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• 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: 07/21/2014
• 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