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 february 28, 2019.Method code #1: 11 - testing of device from same lot/batch retained by manufacturer method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The sample was not returned; however, the photo that was provided was reviewed and confirmed that the oxygenator neck was dislocated from its mounting point.A retention sample from the same product code and lot number was inspected and was found with no anomalies.The most likely root cause of the oxygenator not clamping into the holding pins is due to handling, post shipping, after the tcvs manufacturing process.All oxygenators are 100% visually inspected at several points in the production process.It is likely that the oxygenator neck was dislocated from its mounting point due to 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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