The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass, the valve would not allow fluid to move through it.This event was initially deemed not reportable on (b)(6) 2017; however, on (b)(6) 2017, terumo updated the safety alert, 1124841-06/25/2017-001-c, to a removal, 1124841-06/25/2017-001-r.This event has become associated with the removal and has since become reportable.No known impact or consequence to patient.Product was changed out surgery was completed successfully.
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