It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pco2 reading on the blood parameter monitor (bpm) was drifting.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.Per clinical review on (b)(6) 2014: the bpm was gas calibrated with the 540 calibrator prior to use and the calibration passed.Acetate prime solution (plasmalyte) was used per normal practice, by the prime was buffered with sodium bicarbonate and the prime ph was >7.0.On the initiation of cpb and prior to the first in-vivo recalibration, the partial pressure of carbon dioxide (pco2) was measured on the bpm as about 80mmhg.The lab analyzer measured about 40 mmhg.After the in-vivo recalibration and a number of other re-calibrations, the paco2 measurement of the bpm varied significantly from the lab analyzer and in most cases the bpm was displaying high numbers than the lab analyzer.The other measurements (other parameters) of the bpm were tracking very closely to the lab analyzer.The perfusionist (ccp) stated that no unusual medications were used during the case.The ccp stated it was obvious the bpm was not accurate (in regards to pco2) and no pt interventions were done, due to the pco2 measures of the bpm.The cause was completed successfully, without delay and without associated blood loss.There was no harm observed or reported.
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