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 Date 06/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) had significant value deviation.As a result, an alternate device was employed.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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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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Event Description
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Per clinical review: on (b)(6) 2023, the team experienced a problem with their blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), described as 'all values had significant deviation'.The unit was changed out, with no blood loss, no delay, and the procedure was completed successfully.It was unable to be confirmed whether or not the system was calibrated properly.
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Search Alerts/Recalls
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