TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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Model Number 801188 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Per the manufacturer's technical support specialist, the user facility's perfusionist inadvertently changed the setting from ¿air¿ to ¿95-5¿ causing a calibration failure message and the data logs to show ¿o2 sensor and blender disagree¿ message.The setting was changed back to ¿air¿, performed calibration and the epgs worked as intended.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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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the electronic patient gas system (epgs) lost its calibration.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Search Alerts/Recalls
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