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 mar 31, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation finding: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected samples were not returned for evaluation.Previous complaints were reviewed with their samples received and confirmed the flow lines were present; however, once measured, they were found to be within specification.Representative retention samples were inspected and noted to have flow lines that were measured and found to be within specification.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|