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: 4739 - gas exchanger.Health effect - impact code: 2645 - no patient involvement.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 2306 - component missing.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the pediatric oxygenator did not contain the molded to slide onto the oxygenator holder.As per the user facility, they taped the holder with silk tape as the clip was missing.No patient involvement.The product was not changed out.The surgery was completed successfully.
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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 june 19, 2023.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer; type of investigation #2: 3331 - analysis of production records; type of investigation #3: 4114 - device not returned; investigation finding: 3221 - no findings available; investigation conclusions: 4315 - cause not established.The affected sample was not returned for evaluation; therefore, a thorough investigation could not be performed, and a definitive root cause could not be determined.A representative retention sample was obtained and visually inspected, the connecting ring was securely attached.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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