MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problems Device Reprocessing Problem (1091); Residue After Decontamination (2325)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

No report of injury, procedure delay or cancellation.A steris technician was dispatched to the user facility to inspect the reliance synergy washer.The technician found that no repairs were necessary however, the technician performed preventive maintenance activities and returned the unit to service.No additional issues were reported.The debris present on the instruments was due to improper pre-wash cleaning practices.User facility personnel were unaware that pre-wash cleaning of instruments needed to occur prior to placement in the washer.The reliance synergy operator manual section 4:8, "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 stated they were not aware that they needed to pre-wash the instruments prior to washing in the reliance synergy washer.On 10/24/2017, a steris account manager provided in-service training on the proper pre-wash cleaning practices for instruments prior to use in the reliance synergy washer.The unit is serviced and maintained by the user facility.

Event Description

The user facility reported via medwatch (b)(4) that debris was present on instruments following completed cycles in their reliance synergy washer.

• Brand Name: RELIANCE SYNERGY WASHER
• Type of Device: WASHER
• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7033855
• MDR Text Key: 93221751
• Report Number: 9680353-2017-00083
• 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
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• 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