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

Model Number 2532

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

The customer is conducting an investigation as a follow-up to "inflammation" that occurred to a patient post procedure.The user facility did not disclose the current patient status or if any medical treatment was administered.We understand the user facility is reviewing all their pre- and post-procedural standard operating procedures.The customer contacted steris asking we perform an evaluation of their equipment in an attempt to rule out the amsco 2532 washer/disinfector as a contributor to the reported event.The user facility did not disclose the specific instruments that were used during the procedure subject of the reported event.Steris is working to conduct inspection of the amsco 2532 washer/disinfector.A follow-up report will be submitted once the inspection is complete.

Event Description

The user facility contacted steris requesting functional testing of their amsco 2532 washer/disinfector.

Manufacturer Narrative

A steris service technician inspected the washer/disinfector and found no issues with the function or operation of the device.The technician checked all cycle parameters, verified water pressure, inspected spray arms, rack manifold, dryer fan and the chemical injection pump.The technician ran a test cycle including the use of a washer indicator test and no issues were noted.The technician confirmed the washer/disinfector to be operating properly and returned the unit to service.No additional issues have been reported.

• Brand Name: AMSCO 2532 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: 16204342
• MDR Text Key: 308301381
• Report Number: 9680353-2023-00003
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995192761
• UDI-Public: 00724995192761
• 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: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2532
• Device Catalogue Number: FH120101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• 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