Model Number HEM1 |
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 07/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product is not expected to be returned.The diagnostic log data is expected to be returned for review.When the results are available a supplemental report will be submitted.The device history record review was completed and all manufacturing inspections passed with no non-conformance's.The medwatch submission numbers for the other products involved will be provided in a supplemental report when available.Current literature states there is only modest that the fick calculation is not the standard of care for estimating accurate co/ci values.There is only modest agreement between thermodilution and fick calculation estimates.Thermodilution calculation better predicts patient status and should be used over fick in clinical practice.It is unknown if procedural or patient factors played a role in this event.
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Event Description
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It was reported that there were inaccurate values with the hemosphere instrument.The post-op heart surgery patient was being monitored with a hem1 and swan ganz catheter.The customer states the cardiac output values were frequently running half of the calculated fick values.It would take several hours for the hemosphere and swan values to align/correlate with calculated fick values.This occurred with two hem1 units that had been recently upgraded to be able to run flotrac.The sg catheter was switched from an upgraded hem1 to a second recently upgraded hem1 and to a third hem1 unit.All values were running with close correlation, but the co values were still up to 1l from the calculated fick value and the ci was still off by 0.5.There was no patient harm or injury.There was no inappropriate patient treatment administered.
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Manufacturer Narrative
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The product was not returned for evaluation.The diagnostic log data was returned and reviewed.From the data it was determined that there was no defect found with the product.The reported issue could not be confirmed.The submission numbers for the other products involved in this event are: 2015691-2021-04532, 2015691-2021-04536, 2015691-2021-04537, 2015691-2021-04528, 2015691-2021-04497.
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Search Alerts/Recalls
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