Sorin Centrifugal Pump CP5 System and Control Panel (2017-10-27) — recall 57574
Health Canada — Medical Devices · Canada · 2017-11-10 · Type II
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Reported risk: During internal testing, LivaNova identified a possibility that automatic line closure by The Electrical Remote-Controlled Tubing Clamp (ERC) after detection of an air bubble could take longer than is intended by design in the CP5 system. This could lead to the remote possibility of an air bubble reaching a patient before the clamp closes if the blood flow rate is high and the distance between the bubble sensor and the patient is set at the minimum required by the IFU (1 meter).
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