It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) was reading falsely high potassium (k+) levels.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 the clinical review on (b)(6) 2014: the perfusionist (ccp) stated that this behavior has occurred since the notice of field correction (nfc) (bpm potting) and did not seem to be an issue prior.The issue is the k+ continuously drifts up on the bpm in cases where cardioplegia is used.In cases where cardioplegia (high k+ solution) is not used, the k+ accuracy is acceptable.The drifting occurs after the first in-vivo calibration, where the bpm is matched to the laboratory analyzed result.After the calibration, the k+ rises to levels higher than the laboratory and in some cases, the bpm measured k+ value is 2-3 mmol/l higher than the laboratory analyzed sample.Even after multiple in-vivo recalibrations, the k+ continues to drift up.Other bpm parameters are reasonably in agreement with the laboratory analyzer.The cases are completed successfully, without delay and without associated blood loss.There was no harm observed.
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