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 11/03/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified damage on the chamber and press gasket.The damage created a small hole which subsequently allowed for water to leak from the unit.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 investigation of this event is currently in process.A follow up mdr will be submitted once additional information becomes available.

Event Description

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

Manufacturer Narrative

A steris field service technician inspected the unit and identified that water was leaking due to a damaged press gasket.During inspection of the washer, the technician tested the unit and confirmed that all cycles were completed successfully.As the unit is operational, the user facility has elected to defer further repair to the unit until the washer can be decommissioned for repairs.

• 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: 5261008
• MDR Text Key: 32754091
• Report Number: 9680353-2015-00082
• 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,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• 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?: No
• Date Manufacturer Received: 11/03/2015
• 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