The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass, the valve did not open.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 not changed out surgery was completed successfully.
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