It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit took time for the partial pressure of carbon dioxide (paco2) value change to be reflected.There was no problem found on the paco2 rising after the circulation was stopped.After the circulation was restarted, the displayed value of the paco2 did not go down as was being shown on the blood gas test.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the manufacturer's clinical specialist spoke with the team regarding the incident with their blood parameter monitor (bpm) during a cpb procedure on (b)(6) 2019.The complaint states that it takes time for the bpm paco2 value change to be reflective on the device.The device was gas calibrated without issue.It is not known if this occurrence was before or after the first in-vivo calibration of the pco2.It is not known what the values on the bpm were versus the values from the blood gas analyzer.Additionally unknown information on these two cases are the ph of the prime solution, and the sodium values, both which may cause issues with the chemistries.There was no delay in these surgical procedures.The unit was not exchanged out.There was no blood loss, harm or delay in the continuation of the surgical procedures during these occurrences.
|