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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the view port that connects to the generator was damaged, allowing steam to leak from the unit.The technician replaced the view port, tested the unit, confirmed it to be operating according to specifications, and returned the sterilizer to service.No additional issues have been reported.

Event Description

The user facility reported that steam was leaking from their amsco 400 sterilizer.No report of injury.

Manufacturer Narrative

The technician observed significant white mineral deposits which had corroded the view port's glass.Because of the damage (corrosion) observed to the view port, the technician collected water samples to be tested.Based on the results of the water quality test, and the physical observation of the view port by the technician, the root cause of the damage to the electric steam generator's view port is attributed to the user facility's poor water quality.The facility's incoming water was tested, and the results identified that five 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).These concentrations can cause issues in the operation of the generator and, more importantly, can cause corrosion of some parts.The metals entering the boiler can become concentrated as the solids build in the generator and deposit on the interior components of the generator.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.".Steris notified the customer of the water quality test results and that their water quality is not meeting the required operating conditions.Additionally, steris reminded the customer of the importance of flushing their electric steam generator daily.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: 9917150
• MDR Text Key: 199554526
• Report Number: 3005899764-2020-00020
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1