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 500AHCT |
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 06/01/2022 |
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) readings were inaccurate.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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Evaluation is in progress, but not yet concluded.
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Manufacturer Narrative
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Please disregard the previously submitted medwatch related to this complaint as per a distributor associate, no values were off, the issue was that the unit would not calibrate.Since no values were inaccurate during the clinical activity it was determined that the reported malfunction had no reasonably foreseeable potential to cause an adverse event.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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