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.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.
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The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the water line arm was cracking and breaking off.No patient involvement as this occurred during setup.Product was changed out.Procedure 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 november 07, 2017.The returned samples were visually inspected, during which it was noted that 5 of the 6 heat exchanged water port l-tubes were broken off.Additionally, scuff marks were noted on each returned he housing.A retention sample from the same product code/lot number combination was visually inspected and no anomalies were noted.The units were found to have broken l-tubes of the water ports on the heat exchanger.It is likely that the units were exposed to a force after manufacturing that caused the water tubes to break.It was not able to be determined how or when the damage occurred.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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