The user facility reported to terumo cardiovascular that a much higher rpm needed to flow.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.
|
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on december 9, 2022.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem - added) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h6 (identification of evaluation codes 4114, 3221, 4315) type of investigation #1: 4114 - device not returned investigation findings: 3221 - no findings available investigation conclusions: 4315 - cause not established the affected sample was not returned so a direct investigation could not be performed, and a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|