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

Device Problem Circuit Failure (1089)

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

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

No report of injury, procedure delays or cancellations.The medwatch report is stating that the sterilizer should have a water supply of reverse osmosis (ro) instead of untreated city water.The report also states that the contaminants in the water build up in the unit causing the circuit breaker to trip.Following installation of the amsco 400 sterilizer, the user facility began experiencing water quality issues not only with the amsco 400 sterilizer but with their washers, sinks, etc.The user facility is required and responsible for the quality of the incoming water supply.Approximately 3-4 months after installation, the sterilizer began experiencing calcium build up on the integral generator due to the water quality issues.The generator has been replaced since install due to the water quality issues.The amsco 400 sterilizer is under steris service contract for preventive maintenance and service.Since installation, steris service has provided the necessary cleaning and repairs to the sterilizer to return it to service each time the unit required repair due to issues caused by poor water quality.During each service repair and preventive maintenance, user facility personnel have not expressed any dissatisfaction with the amsco 400 sterilizer or steris's service.The user facility is aware of their water quality issues and have been working to address the issue since the user facility opened in 2014.A steris service technician took water samples from the user facility the week of (b)(6) 2017 to be sent to laboratory analysis for testing.The results of the water samples received on (b)(6) 2017, indicate the user facility has elevated levels of hardness, copper, and zinc.The steris service technician discussed the water sample analysis results with user facility personnel.The source of the elevated levels of copper and zinc in the water is likely the hot water heater; as the water sample taken before the hot water heater did not exhibit detectable levels of copper or zinc.It is recommended to have the hot water heater serviced or replaced.The hot water feed is to the integral steam generator which is experiencing the calcium build up.(b)(4).

Event Description

The user facility reported via medwatch report that deposit build up was occurring in their amsco 400 sterilizer subsequently causing the unit's circuit breaker to trip.

• 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, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 6816989
• MDR Text Key: 83637399
• Report Number: 3005899764-2017-00044
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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