On (b)(6) 2017 it was reported to haemonetics that there was an adverse patient reaction following a procedure utilizing the cell saver® elite® autotransfusion system.The patient was well after the procedure, however later that day the patient became unwell.Device was removed from service pending evaluation from a field service engineer.Further information was provided via email on (b)(6) 2017: the patient had a complicated birth and had been complaining of numbness to the face/difficulty to breathe before operation began, not just with administration of cell salvage blood.This indicates the anesthetic block was too high and is what transfusion believe caused the reaction, not the cell salvaged blood.
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