Model Number 500AHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/07/2022 |
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) blood gas results were not accurate and were drifting off by large quantities.There was no delay.No other details regarding the nature of this event were provided.
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Manufacturer Narrative
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Per user facility's biomedical engineer, the venous probe also does not display results despite frequent calibrations.Evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) observed no inaccuracies during evaluation.The monitor intensity values remained steady for several hours, and basic calibration functions with regard to the blood parameter monitor (bpm) were performed with no apparent issues observed.
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Event Description
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Per clinical review: on 07apr2022, the team at the user facility had a situation with the blood parameter monitor (bpm) described as 'blood gas results are not accurate and drift off by large quantities.' the problem happened while on cardiopulmonary bypass, with no delay.Other surgery related questions are unknown at this time as the end user did not answer them.
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Manufacturer Narrative
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Updated block: b5.
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Manufacturer Narrative
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The reported complaint could not be confirmed.The service repair technician (srt) could not duplicate the reported complaint.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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