Device Dossier

Dialysis system anticoagulation solution

Device Dossier for Dialysis system anticoagulation solution (Dialysis system anticoagulation solution, Class IIb, sponsor Fresenius Medical Care). ARTG…

Intended purpose

Sodium citrate 4% solution is intended for regional anti-coagulation in continuous renal replacement therapies (CRRT) in adults by continuous veno-venous haemodialysis (Ci-Ca CVVHD)or post-dilution continuous veno-venous haemodiafiltration (Ci-Ca post CVVHDF). Sodium citrate 4% solution is for use only with FMC CRRT devices ie MultiFiltrate & multiFitratePRO for the cited blood processing therapies, and having integrated pumps to administer the Citrate solution as well as Calcium. When blood from the extracorporeal circuit is returned to the patient, it mixes with central venous blood which contains calcium that has been continuously administered to the patient, and the anticoagulant effect is neutralized. The solution is typically supplied in a plastic bag with connectors.

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