MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/19/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their washer's test indicator failed after a test cycle.No report of injuries.No instruments were in the unit when the indicator failed.

Manufacturer Narrative

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

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified the lubricant and detergent lines were improperly placed.While this condition did not affect the ability of the washer to perform a cycle, it does indicate the user facility is not using the unit as intended.It was determined that the all clean indicator did not pass as the washer had an incorrect amount of detergent present in the container.The operator manual states, "before operating equipment.Verify detergent supply.Ensure suction tubes are in good condition and placed in proper containers.If supplies are low or have run out, install new containers." also, per the "troubleshooting" section of the operator manual, "if unable to correct the problem with use of the troubleshooting charts, or if a problem occurs that is not described on the chart, please call steris." the technician reviewed the proper use and operation of the consumable pumps and containers with the user facility's central supply supervisor.The cycle subject of the reported event did not contain instruments.No additional issues have been reported after the unit was repaired and the technician has counseled the user facility staff on proper use and operation of the washer's pumps and chemistries.

• Brand Name: RELIANCE SYNERGY 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: 4427659
• MDR Text Key: 16451686
• Report Number: 9680353-2015-00010
• Device Sequence Number: 1
• Product Code: MEC
• 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: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• 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: 12/19/2014
• 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