The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, a black spot was seen in the material.This was discovered during packing/incoming inspection, after unpacking during ongoing production process.No patient involvement.
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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 march 22, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 202, 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: 202 - inappropriate material.Investigation conclusions: 25 - cause traced to manufacturing.The returned sample was inspected upon receipt to confirm a small piece of foreign material on the vr filter.The foreign material was measured and found to be 0.15mm²; which is within specification.Representative retention sample was inspected and noted to have no loose foreign material within the housing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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