TERUMO CARDIOVASCULAR SYSTEMS CORP. 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, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2016 |
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 procedure, the temperature was not reading accurately.The customer used oxygenators temperature readings from the arterial outlet.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the perfusionist observed a larger than usual difference between the measured temperature of the arterial blood exiting the oxygenator and the measured shunt sensor temperature.Usually the difference in temperature was 0.5 - 1.0 degree c, but in this case the difference was about 3 degrees c.According to the perfusionist, the temperature difference would change based on the case events.They made no change to shunt line length or diameter (that could impact flow) and there was no change to patient or operating room conditions.There were no functional issues observed with the accuracy of other shunt sensor measures.They used the monitor to complete the case and it was removed from service after the procedure and sent to manufacturer for evaluation.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) evaluated the temperature using a water bath and a digital multimeter using a thermocouple.The monitor values were compared to those of the lab-platter blood parameter monitor (bpm).The monitor bpm tracked with the lab-monitor bpm within 0.1 degree celsius (c) and both bpms were within one degree c of the temperature displayed on the multimeter.Product meet specifications.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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Search Alerts/Recalls
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