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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 11/04/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The pass-through window is an opening in the facility's wall that is used to move instruments and load racks from one side of the spd room to another.A steam separator is a steam pre-filter assembly (canister) installed to filter the facility's steam supply to improve the quality of the steam.The steam separator is not part of the reliance synergy washer and is the facility's responsibility for ensuring proper maintenance is performed.The steam separator had been decommissioned by the facility back in 2013 as it was not in optimal operating conditions.The user facility did not take action to remove the steam separator after it was decommissioned.A steris service technician removed the steam separator from service and installed a new insulation kit (condensate cooling device) tested it and returned the system and washer to service.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a burn on the steam separator when transferring carts through the facility's pass-through cart window.It is unknown if the employee sought or received medical treatment.

Event Description

Upon further investigation the user facility reported that the employee sought medical attention at the facility's urgent care and was administered first aid treatment; the employee missed no time from work.

• 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: 5261402
• MDR Text Key: 32752458
• Report Number: 9680353-2015-00085
• 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,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: 11/04/2015
• 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