Model Number 550AHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2020 |
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 venous oxygen saturation (svo2) level was abnormal.It was showing at 100% which is not expected.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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Per the manufacturer's product engineer, the monitor was sent for blood loop testing.During testing the engineers were not able to duplicate any errors, discrepancies or problems with the monitor during testing.
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Event Description
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Clinical review: the team had set up the monitor for a cardiopulmonary bypass procedure on (b)(6) 2020 without issue.The monitors hematorcrit saturation (h/sat) had passed its color chip without any error messages.At initiation of bypass, pre in-vivo and post in-vivo calibration, venous saturation was at 100%, whereas the patient values were well below that number.The team used a 1/2 inch cuvette in the venous line, and there were no preset offsets in the system at this time.The team continued use of the device, and just supplemented the venous saturation values with blood gas testing.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician observed the so2 on-screen value was 100% when the color of the sample gradient was brighter.Values could be adjusted using an in-vivo recalibration after approximately 25 minutes.When the sample gradient was darker, adjustments were easier to make.
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Manufacturer Narrative
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The reported complaint was confirmed.Service repair technician (srt) could not duplicate the reported complaint.The hematocrit saturation (h/sat) module passed service mode testing.The h/sat module was replaced as a precaution.The unit operated to the manufacturer's specifications.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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