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 01/29/2015

Event Type  No Answer Provided  

Event Description

The user facility reported a wash cycle on their reliance synergy washer was not properly completed.

Manufacturer Narrative

No injury or procedural delays or cancellations was reported.A steris service technician arrived at the facility, inspected the washer and found two washer fuses had tripped rendering the recirculation pump within the washer inoperable.The user facility stated a generator test was conducted prior to the reported event which caused a sudden power interruption.The steris technician was unable to confirm the cause of the tripped fuses, however stated the sudden power interruption may be related to the reported event.The technician replaced the two fuses, tested the washer and confirmed the unit was operating according to specification.The facility confirmed the cycle subject of the event was the only cycle impacted by the tripped fuses.The issue was identified during the inspection of instruments after the washing cycle was completed as described in section 4.8 of the reliance synergy operator manual.The reliance synergy operator manual section 4.8 states "visual inspection: important: good hospital practice dictates all instruments be inspected for visible debris after processing in the reliance synergy 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." the user facility confirmed they followed their department protocol for reprocessing instruments until clean and free of debris prior to terminal processing.No further issues have been reported.

• 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: 4555001
• MDR Text Key: 19804139
• Report Number: 9680353-2015-00024
• 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
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• 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: 01/29/2015
• 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