MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problem Residue After Decontamination (2325)

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

Event Date 01/05/2015

Event Type  No Answer Provided  

Event Description

The user facility reported a powder residue inside their reliance synergy washers.No injuries or procedural delays or cancellations have been reported.

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 inspected the washer and found that the chemical lines on their knight chemical dosing system were improperly installed.The technician further inspected the washer and found that the spray arms in the chamber and manifolds were clogged with debris.The technician repaired the washer, ran a test cycle and confirmed it to be operating to specifications.No additional issues have been reported.The washer is not under steris service contract and is serviced and maintained by the user facility.In section 6 of the operator manual it states to conduct weekly cleaning on the spray arms.A steris account manager performed in-service training on the proper use and operation of the washer.The steris technician who installed the knight chemical dosing system was advised of the importance of following the proper installation procedures.After reusable instruments are processed in the reliance synergy washer, the user facility must be further process the instruments through an appropriate validated cycle in a healthcare sterilizer.

• 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: 4484800
• MDR Text Key: 5502779
• Report Number: 9680353-2015-00014
• 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: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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: 01/06/2015
• 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