(b)(4).The reported complaint was confirmed.The cooler heater unit was being used for training and it functioned properly before descaling.However, afterwards we noticed that valve one wouldn't open up and made a buzzing noise.We opened up the manifold and it was filled with calcium build-up which we cleaned by hand.We installed the new solenoid valve.The unit operated to manufacturer specifications.A mdr remediation activity related to manufactured devices with a fda product code ¿dwc: controller, temperature, cardiopulmonary bypass heater cooler".This report is a result of the ¿heater ¿ cooler response remediation protocol 02-jun-2016.
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