The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the cap of the reservoir was damaged.It is unknown whether there was a delay in the procedure, whether surgery was completed successfully.Terumo continues to attempt to gain more information regarding this event from the user facility.
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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 19, 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).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 3259, 4307).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: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was not returned so a thorough investigation could not be conducted.A picture of the damage was provided to confirm the event.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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