MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SERIES 1227 CART AND UTENSIL WASHER/DISINFECTOR

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2014

Event Type  No Answer Provided  

Event Description

The user facility reported a steam leak coming from the door seal of their 1227 reliance cart.A small puddle of water formed approximately 2-3 inches near the unit.No injuries or procedural delays/cancellations reported.

Manufacturer Narrative

A steris service technician arrived at the facility, inspected the washer and found a concrete chunk in the washer's condenser which was blocking the drain tubing/connector.The technician resolved this issue by removing the concrete chunk.The technician then ran a test cycle and confirmed the unit to be operating to specification.The steam leak was due to a non-functional condenser caused by an unnoticed concrete chunk that fell into the washer during installation.This unit was installed on june 25, 2014 and is under steris warranty.

• Brand Name: RELIANCE SERIES 1227 CART AND UTENSIL WASHER/DISINFECTOR
• 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: 3958504
• MDR Text Key: 16082255
• Report Number: 9680353-2014-00049
• 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: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• 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