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 21, 2021.H6 (identification of evaluation codes 10, 11, 3331, 3259, 25).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: 3259 - improper physical structure.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt to confirm a broken venous thermistor.A representative retention sample was inspected for damage with no anomalies noted.An engineering change order is currently in process to update procedures related to venous thermistor assembly and inspection.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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