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 may 9, 2019.Upon further investigation of the reported event, the following information is new and/or changed: 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.The returned sample was visually inspected upon receipt.It was confirmed that the venous temperature port was damaged.There was also scuffing noted on the venous inlet.A retention sample form the same lot number was obtained and visually inspected with no anomalies noted on the ports or anywhere on the device.All capiox units are 100% visually inspected at several points in the production process.It is likely that the observed damage caused 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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