Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H6: component code: 4761 - access port health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1354 - leak/splash.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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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 25, 2023.Upon further investigation of the reported event, the following information is new and/or changed: 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, 4210, 4315).Type of investigation: 4114 - device not returned.Investigation findings: 4210 - leakage/seal.Investigation conclusions: 4315 - cause not established.The affected sample was not returned; however, a photo was provided that appears to have blood on the outside of the arterial pigtail.Without a returned sample, a thorough investigation could not be performed, and a definitive root cause could not be determined.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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