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 6, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added lot number and 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) h4 (device manufacture date) 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 affected sample was inspected upon receipt confirming that the one way valve was separated.A representative retention sample was inspected to confirm that the one way valve was intact and securely bonded.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|