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

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the reliance synergy washer/disinfector.The technician reviewed the cycle printout and was able to confirm that prior to the reported event the unit alarmed for a "motor overloads tripped".The technician discussed his evaluation of the unit with user facility personnel and stated that the unit was repairable however, in lieu of repairs the user facility decided to purchase a new steris amsco 5052 washer/disinfector.The reliance synergy washer/disinfector subject of the reported event is approximately 10 years old.The reliance synergy washer/disinfector subject of the reported event is being sent back to steris quality for further evaluation.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that a "humming" noise was coming from their reliance synergy washer/disinfector following the start of a cycle.User facility personnel turned off the power to the unit and removed the instruments.The noise continued followed by a burning smell and smoke coming from the unit.In addition, user facility personnel observed small flames coming from the back side of the unit.The flames were extinguished by user facility personnel by utilizing a fire extinguisher.No report of injury.

Manufacturer Narrative

The reliance synergy washer/disinfector subject of the reported event was sent back to steris quality for evaluation.Visual inspection of the unit confirmed that the fire originated in the motor of the recirculation pump.Further inspection of the recirculation pump motor found that it was operating on both high and low speeds subsequently causing the observed "motor overloads tripped" alarm by user facility personnel.Through follow-up, it was confirmed that during the time of the reported event, user facility personnel acknowledged the "motor overloads tripped" alarm and continued to run the cycle which subsequently led to the reported fire.The operator manual states (pg.7-10), "alarm sounds, and display shows: alarm: motor overload tripped.Press alarm reply touch pad to silence alarm tone.2.Call steris.".

• Brand Name: RELIANCE SYNERGY 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: 16382839
• MDR Text Key: 309633818
• Report Number: 9680353-2023-00005
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 02/15/2023

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: 01/18/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 07/16/2023
• 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