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.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 september 08, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and 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 findings: 213 - no device problem found investigation conclusions: 67 - no problem detected.The returned sample was visually inspected upon receipt with no breakage found.Review of the provided video showed a bubbly liquid flowing out from the gas outside.The returned sample was inspected upon receipt to show no visual anomalies with the device.The blood channel was filled with colored saline, the blood outlet port was clamped and air pressure of 2 kgf/cm2 was applied to the blood channel from the blood inlet port.No leakage was observed inside the housing at the gas channel side.Although a definitive root cause could not be determined, it is possible that a plasma leak could have occurred; however, that was not able to be confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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