(b)(4).This complaint is related to emdr #1828100-2016-00301 and #1828100-2016-00436.The complaint is confirmed.The descaling agent is still available from the manufacturer.This information was passed on to the customer and he will work with his hospital biomed department to order the chemical so that descaling can be done and can continue to be done on a regular basis.A mdr remediation activity related to manufactured devices with a fda product code ¿dwc: controller, temperature, cardiopulmonary bypass heater cooler" was conducted.This report is a result of the ¿heater ¿ cooler response remediation protocol 02-jun-2016.
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The customer reported that during non-clinical activity of the cooler heater unit, the unit is producing too much particulate matter and it may obstruct the passages in the oxygenator heat exchanger.The perfusionist (ccp) feels it is because he cannot obtain the proper chemical for cleaning the units.There was no patient involvement.Per clinical review: on april 12, 2016 clinical services (cs) spoke to the ccp in regards to this issue.The field service representative (fsr) visited this hospital in past week and this customer complained of particulate being in this unit and that he was concerned with the particulate affecting heat exchange performance due to low water flow.He commented to the fsr, he was not able to get the chemicals to keep the unit clean.After my discussion with the ccp, he was told by his hospital biomed that the descaling agent (s-klenz) was no longer available for purchase.Cs checked with technical support and s-klenz is still available from the manufacturer.Cs passed this information on to the ccp and he will work with his hospital biomed department to order the chemical so that descaling can be done and can continue to be done on a regular basis.In review of our records, this unit has not been on a regular preventive maintenance (pm) schedule since 2012 and this could be part of the issue.This complaint is based on concern for loss of function and was mentioned during a pm, not during a case.
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