The user facility reported to terumo cardiovascular that prior to cardiopulmonary, during out of box, the reservoir manifold was clogged / glued.Product was continued to be used, rerouted manifold to another venous port.No consequence or impact to patient.Product was not changed out.Procedure was completed successfully.
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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 october 15, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) 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 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 findings: 3221 - no findings available investigation conclusions: 4315 - cause not established the affected sample was not returned so a thorough investigation could not be conducted.A representative retention sample was reviewed with no physical obstructions in the sampling line.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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