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.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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During laboratory analysis, the product surveillance technician (pst) was able to successfully adjust values, particularly the hematocrit (hct) value, using the in-vivo adjustments throughout the monitor's operating range.The unit operated as intended.
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