This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on november 7, 2016.(b)(4).The sample was not returned for evaluation.A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies, specifically with the inlet and outlet ports.A review of the device history record revealed no manufacturing anomalies.A definitive root cause could not be determined; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
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