Model Number 550AVHCT |
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 Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's subsidiary's clinical specialist, the deviation was not found in any of the measured parameters, only the calculated be value.He found that the calculation formula of the bpm was different than that of the bga.
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Event Description
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It was reported that during use of the device for cardiopulmonary bypass (cpb), the base excess (be) values on the blood parameter monitor (bpm) were deviating from the values gathered by the blood gas analyzer (bga).As mitigation, the values from the bga were used.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 user reported an issue with their blood parameter monitor (bpm) during cardiopulmonary bypass (cpb).Specifically, the user observed a deviation of the base excess value when compared to the values obtained from the lab.It is unclear if this deviation is a positive or negative deviation from the lab blood gas values.There was no delay to the procedure.The unit was not changed out, and the surgery was completed successfully.There was no blood loss or adverse events reported.The user confirmed base excess (be) values from an abl 90 flex blood gas analyzer.
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Manufacturer Narrative
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The reported complaint was not verifiable since the product was not returned for evaluation or testing.Multiple diligence attempts for part return were unsuccessful.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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