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 july 22, 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.Upon evaluation of the complaint sample, it was found, to function as intended.And met all of the product specifications.It is most likely, that the unit had been over pressurized, during use, causing the unit to leak.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test, that each component in the valve is functioning properly.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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