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.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.
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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, 2017.Visual inspection was performed on the returned sample, during which no anomalies were noted anywhere on the device.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.Upon evaluation of the returned sample, it was found to function as intended, and met all of the product specifications.Based on the complaint description, the suction or flow through the ops valve was not sufficient.This is believed to be an issue with the forward flow through the duckbill valve.The reported issue was not able to be replicated; therefore, the complaint was not confirmed.The cause of the issue with the duckbill is due to a process change at the supplier, specifically during the washing/cleaning step.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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