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 october 8, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (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, 213, 67) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer type of investigation #3: 3331 - analysis of production records investigation findings: 213 - no device problem found investigation conclusions: 67 - no problem detected the affected sample was inspected upon receipt where wax was observed on the pump.Most of this wax was cleaned off during the decontamination process.The affected sample was then setup in a simple circuit with water and pressurized to 1500 mmhg for 10 minutes with no leakage observed.A representative retention sample was inspected with no visual anomalies.The retention sample was then setup in a simple circuit with water and pressurized to 1500 mmhg for 10 minutes with no leakage observed.The event could not be duplicated, therefore a definitive root cause cannot be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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