Per the user facility, despite cleaning and calibrating the bpm, the values continued to not align with the blood gases.Evaluation is in progress, but not yet concluded.
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It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) had large discrepancies in the hemoglobin (hb) and gases from the hematocrit (hct) probe.As mitigation, blood gas analysis was used to monitor the patient's levels.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the user reported the bpm during cpb had large discrepancies in hb and venous oxygen saturation (svo2) values when compared to their measured values from the lab blood gas analyzer.They reported during use the hb value was off by 3g, and after in vivo calibration the hb value on the screen did not change.The temperature was reading high when the patient's temperature was 32 degrees.The saturations then read 50-60% when the venous blood gas samples showed mixed venous blood was 75-80%.These inaccuracies resulted in, per the user, triple the number of blood gases needed to verify against the bpm values.Although, there was no delay to the procedure, no injury, blood loss, and the surgery was completed successfully.The user stated this unit was previously sent back, but there were no issues found.However, they continue to see the same issues.The user included two photos which showed blood gases they did recently demonstrating some variances between the bpm and lab blood gas values.
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