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

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found the viewport had been damaged allowing water and steam 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.No additional issues have been reported.

Event Description

The user facility reported water and steam leaking from their amsco 400 sterilizer onto the floor.No report of injury.

Manufacturer Narrative

A steris service technician collected water samples to be tested.The facility's incoming water was tested, and the results identified that four of the critical chemical attributes of water quality were above the maximum requirements for the electric 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 electric steam generator's operating requirements.The amsco 400 sterilizer 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
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• MDR Report Key: 11514646
• MDR Text Key: 244845930
• Report Number: 3005899764-2021-00011
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1