MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Injury (2348)

Event Date 10/04/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their washer was leaking water.The user facility posted a "wet floor" sign and continued to use the unit.An employee slipped on the water, fell, and broke an ankle.The employee sought medical treatment and was placed in a cast due to the injury.Employee subject of the reported event has not yet returned to work.No procedural delays or cancellations have been reported.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified a failed steam supply sump valve.The steam supply sump valve had worn out over time.The leak was condensed water from the steam line which built up in the valve while the unit was not in operation creating a slow leak.The technician replaced the failed valve, tested the unit, and returned it to service.According to the reliance washer 444 operator manual, if water leaks from washer/disinfector then "tighten all clamps and connections.If situation reoccurs, call steris." according to the reliance washer 444 maintenance manual section 4.0: miscellaneous piping components, the washer's sump trap should be rebuilt annually.

• Brand Name: RELIANCE 444 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: 4237047
• MDR Text Key: 22269057
• Report Number: 9680353-2014-00093
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 11/07/2014
• 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