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: 3094 - one-way valve.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 december 1, 2023.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 3331, 4114, 3221, 4315).The affected samples was not returned; however, photos were provided.One photo had an arrow pointing to the positive pressure relief valve, the other photo, the unit appeared to have both positive and negative umbrella valves seated properly in the housing.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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