A haemonetics field service engineer evaluated the cell saver 5 autologous blood recovery system.The haemonetics field service engineer performed functional check and pinch valve occlusion, the system passed functional check, pinch valve occlusion check and was determined fit for use.The cell saver® elite set - 225ml sample was discarded by customer and will not be returned to haemonetics for evaluation, without the physical sample haemonetics is unable to perform further evaluation.
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On (b)(6) 2021 haemonetics was notified of an air detected early fault which occurred on cycle 1 during a procedure in the (b)(6), utilizing the cell saver 5 autologous blood recovery system and cell saver® elite set - 225ml.The fault could not be moved forward; a second machine was then used for the same patient to continue procedure.The second cell saver 5 autologous blood recovery system and cell saver® elite set - 225ml displayed a long empty fault on cycle 1 which was reported to be caused by user, bowl not being scanned and wrong bowl size selected.There was a delay in the procedure and patient had a 9-liter hemorrhage which required the patient to receive a blood transfusion.
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