Model Number 550AHCT |
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 04/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that during priming of the device for cardiopulmonary bypass (cpb), there were issues with the accuracy of the hematocrit (hct) parameter prior to in vivo calibration.An in vivo calibration was done and the device was continued to be used.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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H3: 81 evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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Per the manufacturer's engineer supervisor, the hematocrit saturation (hsat) production blood loop team used bovine blood to assess certain failure modes (e.G.Introduction of air bubbles, improper attachment of hsat probe, smudges on optical surface of the hsat probe), but upon initial review of the data, the system operated as expected (no drifting).
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Manufacturer Narrative
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The reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint.The monitor powered on and passed self-testing successfully.The arterial blood parameter monitor (bpm) and hematocrit saturation (h/sat) probes passed service mode testing successfully.The erasable electronically programmable read only memory (eeprom) did not contain any critical errors.The srt replaced the h/sat probe 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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Manufacturer Narrative
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Per the manufacturer's engineering supervisor, testing of the blood parameter monitor (bpm) was successfully executed providing the necessary objective evidence that the performance of the complaint monitor did not match the accuracy issue described by the end user in the complaint report.However, there were unexpected behaviors from the complaint monitor.There was a spike in the hematocrit (hct) and hemoglobin (hgb) measurements.It is possible that when the cuvette was reattached to the probe, an air bubble was dislodged, causing a temporary spike in the measurements.The spike mimics the shape of spikes induced by air bubbles.It was also observed that there were continuous measurements when the probe was disconnected and reconnected to the cuvette, instead of reading 0 (% or g/dl).It is possible that there is an internal wire within the hsat probe that is loose causing false measurements.It is also possible that the magnet within the hsat cuvette associated with that probe is faulty, allowing for false measurements when the hsat probe is not connected.
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Search Alerts/Recalls
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