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 500AVHCT |
Device Problem
Improper Device Output (2953)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.
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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, there was an error with the partial pressure of oxygen (po2) measurement.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2018, the clinicians calibrated the shunt sensor with both gas a and b for the procedure without concerns or errors.During the initial part of the bypass procedure, prior to the first in-vivo calibration the ph value was reading 1.0 and the partial po2 was reading 100 mmhg.The values from the arterial blood gas (abg) were not known at that point for it was prior in-vivo calibration.The noted differences in the values were rectified after the first in-vivo calibration and the parameter values were consistently accurate the remainder of the procedure.There was no delay due to the perceived inaccuracies on the blood parameter monitor (bpm).The team did not changed out the shunt sensor or the monitor during the procedure.There was no blood loss, nor harm associated with the incident.
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Manufacturer Narrative
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The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst) was unable to verified the reported issue.The monitor was placed in its operate mode for 3 hours at ambient room temperature, arterial and venous blood parameter monitors (bpm) ph, carbon dioxide (co2), oxygen (o2), potassium (k+) and temperatures readings showed no anomalies or any erratic values and were stable.Monitor was placed in its service mode again and another bpm standard reference sensor test (srs) test on arterial and venous bpm's seven channels was performed and remained consistent with the previous testing, with service mode alert limit failures above the +20% to -30% limits set for drift.Monitor was restarted and again passed startup self-diagnostics.No accuracy is claimed before an in-vivo calibration is performed with the 1.69 software.The clinical review action item states that the clinicians acknowledged that after in-vivo calibration was performed the parameter values were consistently accurate the remainder of the procedure.The monitor operated as intended following in-vivo calibration; as per the instructions for use (ifu) states.Per central engineering, there was no claim of accuracy before in-vivo process had taken place.As a result, blood loop testing is not required.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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