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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/11/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified damage to the unit's drying valve.The technician replaced the drying valve body, tested the unit, and confirmed it to be operating according to specification.Section 1 of the operator manual for the reliance synergy washer/disinfector states, "to prevent slips, keep floors dry.Promptly clean up any spills or drippage.For spills or drippage of detergents or other chemicals, follow safety precautions and handling procedures set forth on detergent or chemical label and/or material safety data sheet (msds)." the dhr for the unit was reviewed and no issues were noted.The unit was returned to service and no additional issues have been reported.

Event Description

The user facility reported their reliance synergy washer/disinfector was leaking water.No report of injury.

• Brand Name: RELIANCE SYNERGY 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: 5290132
• MDR Text Key: 33879896
• Report Number: 9680353-2015-00087
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

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