MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 220 CART WASHER

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2014

Event Type  No Answer Provided  

Event Description

The user facility reported the washer was leaking water.The water spread into the operator's working area.No injuries or procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived at the facility, inspected the washer and found the gasket holder was not properly attached to the door causing the water leak.The technician reattached the door seals, completed a test cycle and confirmed the unit was operating to specification.The gasket holder damage was caused by improper loading of the cart into the washer.While onsite, the technician instructed the facility on the proper way of loading carts into the washer.The unit was installed in 1999 and has not been under a steris service contract since 2007.

• Brand Name: RELIANCE 220 CART WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3601638
• MDR Text Key: 15204492
• Report Number: 9680353-2014-00014
• Device Sequence Number: 1
• Product Code: FLH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• 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?: Yes
• Date Manufacturer Received: 01/10/2014
• 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