MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 333 WASHER/DISINFECTOR

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 12/14/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Steris monitors relevant websites and social media sources per our social media policy to identify potential complaints.Through this process, steris identified an anonymous post reporting that their reliance 333 washer was leaking water.Steris responded and provided contact information including a phone number however steris has not received a response.The reported event may be the result of the following circumstances: the drain pump connection is not working efficiently, the water level switch in the condenser is not operating properly, or the cold water pressure level is less than 30 psi (dynamic).Any of the aforementioned may result in water permeating the condenser filter.Based on the information provided in the anonymous posted this event appears to meet our reporting criteria for medical devices.A follow up report will be submitted if additional information becomes available.

Event Description

The complainant reported that their reliance 333 washer was leaking water.The complainant stated, "washer pouring water out of condenser filter.Changed drip pan valve.Condenser valve and still water coming out.Comes out when condenser fills with cold water and blower running at very end of cycle.Cold water flows into condenser and approx 10 seconds or so later the condenser valve opens.By this time, water is coming out of filter.Any thoughts?".

• Brand Name: RELIANCE 333 WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• 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: 5357576
• MDR Text Key: 36003439
• Report Number: 9680353-2016-00002
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2015
• 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