MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; CART WASHER/DISINFECTOR

Model Number	7053HP
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that "black flakes" were observed in the chamber of their amsco 7053hp washer/disinfector.User facility personnel followed their post-inspection procedures according to their good hospital practices and inspected all instruments present in the chamber.Procedure delays were reported as the instruments had to be reprocessed.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the amsco 7053hp washer/disinfector and observed "black flakes" on the rack surface.No issues were noted with the function or operation of the washer/disinfector.Upon further investigation, it was confirmed that the observed flakes were not originating from the unit or its accessories, but instead was attributed to the user facility's water quality/filtration system.The technician also observed that the water supply strainer to the washer was clogged with debris due to the drain line not being installed correctly by user facility personnel subsequently causing backflow of contaminants into the washer's chamber.The technician counseled user facility personnel on the importance of properly installing and cleaning the drain line.The user facility was provided a replacement rack.The amsco 7053hp washer/disinfector was confirmed to be operating to specification, returned to service.The user facility has committed to addressing the issue(s) with their water quality/filtration system.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: CART WASHER/DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20362471
• Report Number: 9680353-2024-00032
• Device Sequence Number: 8003890
• Product Code: MEC
• UDI-Device Identifier: 00724995176655
• UDI-Public: (01)00724995176655(11)240214
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: 7053HP
• Device Catalogue Number: FH19072
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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