Terumo has received the device for evaluation; however, 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: 4739 - gas exchanger.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 may 8, 2023.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, device evaluation); h3 (device evaluated by manufacturer) ; h4 (device manufacture date); h6 (identification of evaluation codes 10, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected and no anomaly such as breakage was found.The images provided confirmed the cross section of the fiber on the gas outlet side was discolored red and a transparent liquid was found on the gas inlet.The returned sample was leak tested after rinsing.The blood channel was then filled with color saline solution, the blood outlet side was clamped and a pressure of 2kgf/cm2 was applied from the blood inlet side into the blood channel.No foaming was found.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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