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
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 03/30/2021 |
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 blood parameter monitor (bpm) presented an inaccurate hemoglobin (hgb) reading that was higher than normal.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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Manufacturer Narrative
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Updated blocks: b5, h3 and h6 the reported complaint is not verifiable.Multiple diligence attempts for part return were unsuccessful so an evaluation could not be completed.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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Event Description
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Per clinical review: at the time of this clinical review, there was no additional information available.The information known is that the team had an incident with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure on (b)(6)2021.It is unknown if the stated inaccurate hemoglobin readings during bypass was before an in-vivo calibration or after the calibration.Additionally, the delta in the hemoglobin numbers is unknown.The clinician did exchange the bpm for a different one and the case proceeded without issue.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss.
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Search Alerts/Recalls
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