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).
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