(b)(4).As per field service representative (fsr), the reported issue was resolved before the case started.The fsr visited the hospital and verified there were no issues with the temperature module.The temperature module was measuring arterial temperature on the red channel and venous temperature on the blue channel.The system was set up with a connected dry circuit and both channels were reading temperature.Both channels of the temperature module were tested with the probes and no issues were found.The alarms functioned as well.The device was operating within manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the new arterial probe had to be disconnected/connected a couple of times before the temperature registered.Once registered, it worked without issue.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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