It was reported that during use of the device for a cardiopulmonary bypass procedure, the heating and cooling system (tcm ii) shut down during rewarming phase of case.As a result, the product was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the clinical specialists spoke with the field service representative (fsr) regarding the incident.This tcm ii had been used in a couple of long cases back-to-back.During rewarming of the patient (in the 2nd case), without warning, the entire tcm ii shut down with loss of functionality and displays.According to user facility perfusionist, there were no error codes, noises, or warning of any kind prior to shutdown of the unit.He had a back-up unit and the unit was changed out.The case was completed successfully, without delay of the surgical procedure and without associated blood loss.There was no harm observed.
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