The user facility reported to terumo cardiovascular that during pre cardiopulmonary bypass, there were specks seen on the reservoir.As per user facility, the marks were difficult to see or differentiate from patient blood coming back through.No known consequences or impact to patient.The product was not changed out.The 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 october 2, 2019.Upon further investigation of the reported event, the following information is new and/or changed: a3 (updated patient information - patient sex).B5 (describe event or problem - occur during priming).D4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H4 (device manufacture date).H6 (identification of evaluation codes (11, 4114, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 4114 - device not returned.Method code #3: 3331 - analysis of production records.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned for evaluation.Pictures provided with the complaint confirmed the existence of the specks.A representative retention sample was reviewed and there was no contamination within the device.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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