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 Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/02/2018 |
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 a temperature discrepancy.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the perfusionist set up and calibrated his blood parameter monitor (bpm) shunt sensors with both gas a and gas b, along with placing the potassium (k+) code in the monitor prior to initiation of bypass on (b)(6) 2018.He did his first in-vivo calibration without problem.Thirty (30) minutes into the cpb procedure, he noticed that his sensor temperature was reading 40.5 celsius (c) and the patient's actual temperature was listed as 37.0 c.This difference alerted him to do another in-vivo calibration.He placed his new blood gas analyzer values in the bpm, and just as the machine was reverting back to operate mode, the k+ parameter read 8 meq (he had placed 4.0 meq in the machine), and the machine then gave him a f101 error message.This error message is an arterial bpm hard failure.He turned the bpm off and back on, but was only able to choose a configuration without the arterial bpm.He proceeded with using the unit in the hemoglobin, hematocrit saturation module (h/sat) configuration without issue.The incident did not delay the continuation of the surgical procedure.They supplemented the values with blood gas values from a blood gas analyzer.There was no blood loss or harm associated with the event.
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Manufacturer Narrative
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The reported complaint was not verifiable.During laboratory analysis, the product surveillance technician (pst) observed the monitor to operate for 23 straight hours (in operate mode) as intended.Next, a water bath temperature test was set-up to test for the temperature inaccuracy.The monitor passed initial startup self-diagnostics with no errors.The monitor then produced a f101 error and had to be restarted (error removes the blood parameter monitor (bpm) from the configuration).When restarting, the monitor also produced an f0a1 error, bpm is taken out of configuration.Water bath temperature testing for inaccuracy cannot be performed since the bpm is disabled due to the errors.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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