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: insufficient information.Health effect - clinical code: 4582 - no clinical, 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 26, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem); 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 and device evaluation); h3 (device evaluated by manufacturer); h4 (device manufacture date); h6 (identification of evaluation codes 4582, 10, 3331, 213, 67).Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.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 returned sample was inspected upon receipt and noted that the water out port was damaged.The sample was set up with tubing and water was run through the water side for about an hour, no leaks were noted.Using the tubing that was received on the sample, it was then circulated at 7lpm with a saline solution through the blood side for about an hour, no leaks were noted.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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