MAUDE Adverse Event Report: STERIS CANADA ULC VISION 1330L CART WASHER/DISINFECTOR

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fall (1848)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the cart washer and found that the solenoid valve was not operating properly.The solenoid valve controls the flow of detergent to the chemical dosing station.As the solenoid valve failed to open, this caused the squeeze tube assembly on the chemical dosing station to split allowing detergent to leak from the unit.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that an employee slipped and fell on detergent leaking from their vision 1330l cart washer/disinfector resulting in a scrape on their leg.No medical treatment was sought or administered and the employee returned to work.

• Brand Name: VISION 1330L CART WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 11679210
• MDR Text Key: 248172998
• Report Number: 9680353-2021-00020
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• 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: 03/26/2021
• 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