TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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Model Number 811113 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb)procedure, there was a communication error between the centrifugal pump and the central control monitor (ccm).The issue resolved itself once the system was rebooted.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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The reported complaint could not be confirmed.The service repair technician was unable to duplicate the reported issue.The unit operated to the manufacturer's specification.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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