MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility stated that all instruments processed in these cycles were visibly inspected and sterilized prior to use in patient procedures.The steris reliance 444 washer/disinfector operator manual states on page i, "steris does not intend, recommend nor represent in any way that this reliance 444 single-chamber washer/disinfector be used for the terminal disinfection or sterilization of any regulated medical device.Reliance 444 single- chamber washer/ disinfectors are intended only to perform an initial step in the processing of soiled, reusable medical devices.If medical devices will be contacting blood or compromised tissues, such devices must be terminally processed in accordance with device manufacturer's instructions and/or good hospital practices before each use in human patients." the steris operator manual also states on page 4-12, "good hospital practice dictates that all instruments be inspected for visible debris after processing in the amsco reliance 444 single-chamber washer/disinfector - international.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." a steris service technician arrived on-site and could not duplicate the reported event.The reliance 444 washers and knight chemical dosing systems were operating properly.No additional issues have been reported.A steris account manager provided in-service training on proper use and operation of the washer and knight chemical dosing systems.No additional issues have been reported.

Event Description

The user facility reported that four knight chemical dosing systems were not properly dispensing detergent when running cycles within their reliance 444 washers/disinfectors.

• Brand Name: RELIANCE 444 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6175230
• MDR Text Key: 62524886
• Report Number: 9680353-2016-00124
• 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
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2016
• 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
• Patient Outcome(s): Other