TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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Model Number 500AVHCT |
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 05/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's subsidiary, at the beginning of cpb the bpm was reading 1.0 for k+ and the actual value was 3.4.During cpb the bpm read up to 7.0 when the actual value was 4.6.
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Event Description
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It was reported that during the use of the device for cardiopulmonary bypass (cpb), the potassium (k+) values from the blood parameter monitor (bpm) did not match the actual blood gas values.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) 2022, the team experienced a problem with they blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), whereby it was reading abnormal potassium (k+) values, not in agreement with the lab values.The team continued to use the unit, with no delay, no blood loss, no change out, and successful completion of the procedure.
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