It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) was giving inaccurate hemoglobin and hematocrit values.As a result, manual gas values were taken.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during set-up for a cpb procedure on (b)(6) 2019, the bpm passed its color chip test without issue.The first hemoglobin and hematocrit values were higher than expected, and were not tracking well, until the first in-vivo calibration occurred.The perfusionist stated that once the in-vivo calibration occurred, the values for both the hemoglobin and hematocrit were more in line with the lab values from the blood gas analyzer.The need for an in-vivo recalibration was reiterated, and that the device has published accuracy values that are not in line with expected values until after the first in-vivo calibration.The unit was not exchanged out.There was no blood loss or harm related to the event.There was no delay in the continuation of the surgical procedure.
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The reported complaint was confirmed.Per the user facility, an in-vivo calibration had not been done.The user has been advised that the monitor does not have accuracy until an in-vivo calibration is completed.The unit is operating as intended and will not be returned for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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