The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there were clots found in the oxygenator and the blood gases were dropping rapidly.They were on by-pass for about 3 hours.They were about to come off bypass in about 5 minutes.That is when bioglue was administered to the patient.Within about 5 minutes of bioglue administration, little clots were noticed in the oxygenator and the blood gases were dropping rapidly.The customer feels strongly that the bioglue got into the circuit and caused the issues.There was approximately 240 ml of blood loss.The product was changed out.The surgery 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 november 9, 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).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).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: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected and did not find any anomaly including breakage.After rinsing and drying, the sample was installed into a circuit consisting of tubes, and the pressure drop when circulating bovine blood (hct: 35%, temp: 37 degrees) was measured.It was confirmed to meet the factory's specifications and no obstruction was found.Based on the investigation result, no anomaly that could lead to clot formation was found in the actual sample.Review of the manufacturing record and the incoming inspection record of the actual sample confirmed that there was no anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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