MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE 444 WASHER/DISINFECTOR

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance 444 washer/disinfector and spoke to user facility personnel regarding the reported event.The technician learned that the employee was attempting to manually clear an obstruction from the door when their finger was pinched by the conveyer arm resulting in the reported event.The technician inspected the washer and found that the teflon rack loading sliding guide which is part of the loading rack assembly inside the washer was missing a screw and was misaligned.This caused the racks that sit on the loading rack assembly to shift during the wash cycle and jam the door.The washer was installed in 2005 making it approximately 17 years old and is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.The reliance 444 operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and upper panel.Do not push on top portion of doors; do not push on door when door is rising; do not push on door when door is jammed." the operator manual further states (1-1), "warning - personal injury hazard: if an obstruction is present in the wash chamber door and door is unable to raise, do not attempt to remove obstruction from under the door.Door cables may have slackened and door may close at high speed when obstruction is removed.Call a qualified service technician to safely remove obstruction." the technician replaced the screw to the loading rack assembly, tested the unit, confirmed it to be operating according to specification, and returned it to service.The technician counseled the customer on the safe operating protocols, specifically to call a qualified service technician to safely remove obstructions.No additional issues have been reported.

Event Description

The user facility reported an employee obtained an injury to their finger while operating their reliance 444 washer/disinfector.The employee self-applied a bandage and returned to work.

• Brand Name: RELIANCE 444 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: 13825702
• MDR Text Key: 290952008
• Report Number: 9680353-2022-00011
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• 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: 02/18/2022
• 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