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 13, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3259, 4307).Type of investigation: #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was not returned so a thorough investigation could not be conducted.A representative retention sample of the same lot number was reviewed for damage to the venous inlet on the reservoir with no damage observed on the sample.Due to an increase in broken venous thermistor complaints and internal discovery, a 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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