It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the hemoglobin (hgb) and hematocrit (hct) readings were inaccurate.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during cpb on (b)(6) 2020, the blood parameter monitor (bpm) was powered up and passed color chip test without an issue.During cpb, approximately four hours into the bypass run (post in-vivo calibration) the bpm started to give inaccurate numbers on the hct and hgb, and the venous saturation value did not appear.There was nothing wrong with the patient, or the physical probe or cuvette, for it had worked perfectly up until this issue occurred.The team cycled power, and the same result of the hgb and hct numbers going up and down and the venous saturation levels not reading.There were no issues with the arterial gases.The team opted to exchange the unit during the procedure.
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