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 april 11, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes (10, 11, 3331, 3259,4307).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331- analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.Visual inspection of the returned sample confirmed the damage to the venous inlet leur cap and the tyvek bag.A representative retention sample from the same product code and lot number combination was visually inspected and found to have no damages or anomalies, specifically with the blood inlet port on the oxygenator.All oxygenators are 100% visually inspected at several points in the production process.The packaging of the product also ensures protection against damage to the ports of the oxygenator during shipping.It is likely that the port was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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