It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the hematocrit (hct) values post in-vivo were approximately six to ten points off from blood gases.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: it was unknown when this occurred, but about half of the cases between march or april until now, the blood parameter monitor (bpm) has been giving the perfusion team about a six to ten point difference in the hct values.The unit passes its color chip test without issue.They re-invivo the units with the first blood gas, and "hematocrit drift" has been noted.In some instances it was between 6 and 10 points, but in others it does get better with repeated in-vivo calibrations.The unit has not been exchanged out on the cases.There has not been a delay in these surgical procedures, and no blood loss or harm has been reported due to this concern.
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