MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the view port had become damaged allowing water to leak from the sterilizer.The technician replaced the view port, tested the unit, confirmed it to be operating according to specifications, and returned it to service.The technician collected water samples to test the facility's incoming water to ensure that their incoming water supply remains within the unit's operating requirements.The results are still pending.A follow-up mdr shall be submitted when the results become available.No additional issues have been reported.
Event or Problem Description
The user facility reported water was leaking from their amsco 400 sterilizer onto the floor.No report of injury or procedure delay.
Additional Manufacturer Narrative
Results for the facility's collected water samples identified that four of the critical chemical attributes of water quality were above the maximum requirements for the carbon-steel steam generator as stated in the amsco 400 sterilizer operator manual (table 5-1.Required feed water quality for carbon-steel steam generators).The user facility is responsible for ensuring that their incoming water supply remains within the carbon-steel steam generator's operating requirements.The amsco 400 operator manual states (3-1), "water quality - supplied must be within specifications.Improper water quality adversely affects equipment operation." the technician notified the customer of the water quality test results and that their water quality is not meeting the required operating conditions.The user facility has committed to making the necessary improvements to the facility's incoming water quality.No additional issues have been reported.

• Brand Name: AMSCO 400 STERILIZER
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19326009
• Report Number: 3005899764-2024-00021
• Device Sequence Number: 14098745
• Product Code: FLE
• UDI-Device Identifier: 00724995209254
• UDI-Public: 00724995209254
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/15/2024

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: 05/15/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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