MAUDE Adverse Event Report: STERIS CANADA CORPORATION AUTOMATIC TRANSPORT SYSTEM TO RELIANCE SYNERGY WASHER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2013

Event Type  No Answer Provided  

Event Description

The user facility reported that the automatic transport system installed along a reliance synergy washer/disinfector had malfunctioned, causing the load racks to incorrectly insert into the washer.An employee injured her shoulder while attempting to remove the racks.The employee sought and received medical treatment due to the injury and has since returned to full work duties.No procedural delays/cancellations reported.

Manufacturer Narrative

During communication with a steris account manager, the user facility stated there had been an event involving a fully loaded rack on the automatic transport system (ats).An employee initiated a pushing sequence to load the rack into the washer, however the process could not be completed as the rack was not correctly aligned on the ats conveyer.The employee then turned off the ats, and repositioned the rack into the washer.It was during this adjustment that the employee received the shoulder injury.Following notification of the event, a steris service technician arrived at the facility, evaluated the ats and noticed that the racks were drifting while loading into the washer.To resolve the issue, the technician leveled the conveyer legs and ensured the legs were locked into position.The technician tested the conveyer system, confirmed the unit was operating to specification and returned the unit to service.

• Brand Name: AUTOMATIC TRANSPORT SYSTEM TO RELIANCE SYNERGY WASHER
• Type of Device: AUTOMATIC TRANSPORT SYSTEM
• 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: 3988677
• MDR Text Key: 19718538
• Report Number: 9680353-2014-00053
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• 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: 07/11/2014
• 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