The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, they noticed a cracked venous temperature port.No known impact or consequence to patient.Product was changed out with a 5 minute delay.Procedure was completed successfully.
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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 26, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H6 (identification of evaluation codes 11, 3331, 4114, 3259, 25).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: 25 - cause traced to manufacturing.The affected sample was not returned for evaluation.Due to an increase in broken venous thermistor complaints and internal discovery, an investigation has been conducted resulting in enhanced inspection of the venous thermistor.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.A change 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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