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 07/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's subsidiary, three minutes after starting circulation the value displayed on the bpm was 1.0 and the measured value was 3.4.50 minutes after starting circulation (administrated cardioplegic solution) the value displayed on the bpm was 6.6 and the measured value was 3.9.One hour after starting circulation (administered mean arterial pressure) the value displayed on the bpm was 5.5 and the measured value was 4.3.
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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) measured value was low.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 their blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb) whereby the measured potassium value was inaccurate, even after repeated in-vivo recalibrations.The device was not changed out.There was no delay and no blood loss, and the procedure was completed successfully.
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