MAUDE Adverse Event Report: STERIS CANADA CORPORATION UNIVERSAL TRANSFER CART; WASHER

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Date 09/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris account manager arrived onsite and inspected the transfer cart subject of the reported event.He did not find any issues with the transfer cart.The unit was confirmed to be operating according to specification and returned it to service.No additional issues have been reported.This model of transfer cart is manufactured without a drain.It is specifically designed to prevent draining to contain excess water.Section 1 of the operator manual for the universal transfer cart states, "to prevent slips, keep floors dry.Promptly clean up any spills or dripping." the account manager provided in-service training to the user facility staff regarding the proper use and operation of the transfer cart.

Event Description

The user facility reported their universal transfer cart did not drain causing water to overflow from the basin and onto the floor.No report of injury.

• Brand Name: UNIVERSAL TRANSFER CART
• Type of Device: WASHER
• 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: 5166565
• MDR Text Key: 28904561
• Report Number: 9680353-2015-00072
• 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
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2015
• 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