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 august 6, 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) h4 (device manufacture date) h6 (identification of evaluation codes 4114, 3331, 11, 3221, 4315) method code #1: 4114 - device not returned method code #2: 3331 - analysis of production records method code #3: 11 - testing of device from same lot/batch retained by manufacturer results code: 3221 - no findings available conclusions code: 4315 - cause not established the affected sample was not returned for evaluation; therefore, a thorough investigation cannot be performed.A representative retention sample from the same lot number was obtained and visually inspected; it was confirmed that all ports and the reservoir lid were intact and no anomalies noted related to the damage on the ports and reservoir lid 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 was caused by a shock force due to mishandling after unboxing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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