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, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) temperature reading dropped, reading 29-30 degrees celsius.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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Evaluation is in progress but not yet concluded.Per the user facility's biomedical engineer, on (b)(6) 2022, the temperature reading on the unit dropped, reading 29-30 degrees celsius.The unit was flushed and there was no change.The unit was troubleshot and the arterial cuvette was changed out.Recalibration of the unit corrected all numbers with the exception of the blood temperature reading.On (b)(6) 2022, the temperature reading corrected itself and functioned correctly for the next couple of days.On (b)(6) 2022 the temperature reading dropped again with readings between 29-33 degrees celsius.The unit was flushed again with no improvement.Patient was unaffected by the issue.Both the water heater and the patient temperatures were stable at about 38 degrees celsius and 36-37 degrees celsius respectively.
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Event Description
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Per clinical review: on (b)(6) 2022, the team experienced a problem with their blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), whereby the temperature was reading incorrectly.The unit was not changed out, there was no delay or blood loss, and the procedure was completed successfully.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) booted up the monitor without failure and the erasable electronically programmable read only memory (eeprom) indicated zero error codes.The temperature was monitored using a multimeter and a thermocouple throughout the monitor's operating range.No significant discrepancies or sudden changes were observed.It was determined that the bpm met specification.During testing at the service center, the service repair technician also could not duplicate the reported complaint.The unit operated to the manufacturer's specifications.
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Manufacturer Narrative
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The reported complaint could not be confirmed.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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