It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial temperature reading was half degree lower on the blood parameter monitor (bpm) than anticipated.The device was not changed out, as they continued to use the unit for the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical summary on (b)(6) 2015: since the software upgrade of the bpm from version 1.65 to 1.69, this perfusionist (ccp) has observed that the shunt sensor temperature measurement is measuring lower than previously observed with software version 1.65.According to the ccp, the bpm shunt sensor temperature was usually about one degree celsius less than the oxygenator outlet (arterial blood) temperature, but since the software upgrade the shunt sensor temperature is about 1.5 degree celsius lower than the oxygenator outlet.This did not impact the procedure nor change management of cpb in anyway.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.The instructions for use (ifu) does address an expected difference between the shunt sensor temperature and the oxygenator outlet temperature.The temperature at the shunt differs from the arterial outlet as the shunt is a distance away from the oxygenator outlet and the shunt is connected to small diameter tubes in the cpb circuit which results in cooling of the blood.The temperature accuracy of the shunt sensor has been improved in software version 1.69 and is part of the improved accuracy claims in shunt sensor performance.The measured temperature (post 1.69) is actually a more accurate temperature than in version 1.65, but the difference has been observed by a number of users since 1.69 has been completed.The new temperature algorithm was not included in the ifu supplement that was given to users after the upgrade was completed.
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