TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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Model Number 500AHCT |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's subsidiary, five minutes after cpb started the k+ value gradually increased and went from 4.0 to 8.0.After recalibrating the bpm, the issue occurred.K+ values from the lab were normal values.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) had abnormal potassium (k+) values.The surgical procedure was completed successfully.There was no delay, an approximate 10 milliliters (ml) blood loss, and no adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint was not verifiable.Multiple diligence attempts for part return and additional information were unsuccessful.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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Event Description
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Further information was received that there was no blood loss during the procedure.Per clinical review: the team calibrated the shunt sensor and blood parameter monitor (bpm) without issue for a cardiopulmonary bypass (cpb) procedure on (b)(6) 2018.Five minutes after commencing cpb, before the first in-vivo calibration the potassium (k+) level on the bpm went from 4.0 to 8.0.The team performed the in-vivo calibration and the same result occurred, the value started at 4.0 and resulted at 8.0 without any known change in blood k+.According to the information available at the time of the clinical review, the blood gas analyzer value for k+ was normal (+.5 to 1.0).The team did not exchange the shunt sensor or the bpm, they relied on intermittent k+ values from the blood gas analyzer.There was no blood loss or harm associated with the incident.There was no delay in the continuation of the surgical procedure.
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