The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the perfusionist noticed a crack in the arterial side stop cock of the sampling port.No patient involvement as this occurred during setup.Product was changed out.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 december 19, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was visually inspected.A crack along the female l-shaped connector was found, while still connected to the luer port.A retention sample from the same product code and lot number combination was visually inspected and confirmed to not have any damages or cracks on the l-shaped connector.Replication testing was performed on a retention sampling manifold line.The l-connector was over-tightened onto a port of the reservoir, which lead to the l-connector cracking along the part, in the same way as the returned sample.It is likely that during setup of the circuit, the l connector been over-tightened, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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