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 01/14/2021 |
Event Type
malfunction
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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 temperature measurement was not tracking properly.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Event Description
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Per clinical review: the manufacturer clinical specialist spoke with the perfusionist regarding an incident the team had with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2021.During the procedure it was noted that the patient's temperature was approximately 28 degrees celsius, the bpm was reading seven degrees below what the patient's temperature was.The perfusionist team does understand per practice and understanding from use of the bpm for years, that the thermistor in the disposable and the corresponding reading does not correlate to patient temperature.The concern was the potential hydrogen (ph) and the partial pressure of carbon dioxide (pco2) post in-vivo was very inaccurate.The concern about the temperature being drastically different than what they would normally see on the bpm, cooling to the same temperature on various other surgeries.The team opted to exchange the unit and all values, including the temperature were trending as expected.There was no blood loss or harm associated with the event.There was no delay in the continuation of the surgical procedure.
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the bpm to power up and a 'f0a1' code logged in the erasable electronically programmable read only memory (eeprom).During visual inspection with a slight amount of lateral pressure, the tip of the thermistor detached from the arterial bpm.The tip of the thermistor was damaged resulting in poor temperature tracking.The product was sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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