The actual device and a photo were returned to the manufacturing facility for evaluation.A review of the photo during the actual use provided by the customer confirmed the reported complaint.The presence of white clot-like substance can be seen adhering around the fluid level graduation of 100 - 300ml.Visual inspection of the actual device found it had been marked with a large black circle and a small black-circle.In the small circle, the adhesion of white clot-like substance was found.In the large one, no such a substance was visible.There was no adhesion of white clot-like substance on the remainder of the reservoir.The white clot-like substance was fixed with glutaraldehyde solution and a specimen was sampled.Magnifying inspection of the specimen found it had a layered structure.The white clot-like substance was subjected to a ft-ir qualitative analysis and identified as protein.The white clot-like substance was subjected to a sem/edx elementary analysis and found to consist of c (carbon), o (oxygen), n (nitrogen), p (phosphorus) s (sulfur) and na (sodium).Electron microscopic inspection of the white clot-like substance found degeneration had progressed.This prevented the traces of blood corpuscles and fibrin nets from being observed.A review of the device history record of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file found no report of this nature with the involved product/lot# combination.Based on the evaluation result, the white clot-like substance is likely to be protein-origin, consisting of carbon, oxygen, nitrogen, phosphorus, sulfur and sodium.From the results of the sem/edx elementary analysis and the electron microscopic inspection, the scenario or cause of the formation of the substance cannot be determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
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