There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.It was found that the motor was rotating slowly thus the technician attempted to clean the pump but this did not solve the problem.The patient pump will be replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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