MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 2532 SINGLE CHAMBER WASHER/DISINFECTOR

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bruise/Contusion (1754); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a decontamination cycle for their amsco 2532 single chamber washer/disinfector, small flames were observed within the bottom of the chamber.User facility personnel opened the chamber door and extinguished the flames.No report of injury.
Additional Manufacturer Narrative
Through follow-up with user facility personnel and the steris service technician it was confirmed that the amsco 2532 single chamber washer/disinfector experienced an alarm #12 (sump overtemperature) after the cycle was initiated.User facility personnel acknowledged the alarm and soon after, observed the reported event.The steris technician inspected the unit and found that the rubber seal of the debris screen assembly showed evidence of melting.User facility personnel stated that the debris screen may not have been installed properly prior to the start of the decontamination cycle.The heating element is directly below the location of where the debris screen is installed.As the heating element overheated and the debris screen was not installed properly, the rubber seal of the debris screen came into contact with the heating element, creating a source for combustion.The operator manual states (pg.74), "reinstall debris screen in sump.Important: slightly push on debris screen to ensure debris screen correctly rests on sump surface.No gap should be noted between the debris screen gasket and the sump surface." the steris service technician repaired the amsco 2532 single chamber washer/disinfector, ran a test cycle, confirmed the unit to be operating properly, and returned it to service.The steris service technician counseled user facility personnel on the proper use and operation of the amsco 2532 single chamber washer/disinfector and the importance of properly installing the debris screen.No additional issues have been reported.

• Brand Name: AMSCO 2532 SINGLE CHAMBER WASHER/DISINFECTOR
• Common Device Name: 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19333217
• Report Number: 9680353-2024-00018
• Device Sequence Number: 3063220
• Product Code: MEC
• UDI-Device Identifier: 00724995192907
• UDI-Public: 00724995192907
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown