Device Dossier

Haemofilter

Device Dossier for Haemofilter (Haemofilter, Class IIb, sponsor Vantive). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

The Prismaflex HF1000/HF1400 set is a single use device that provides blood purification through a semipermeable membrane. The Prismaflex HF1000/HF1400 set is for use only in conjunction with the Prismaflex control unit or with the PrisMax control unit. All treatments administered via the Prismaflex set must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment. If patients suffer from acute kidney injury and / or volume overload, the Prismaflex HF1000/1400 set is indicated for continuous renal replacement therapies (CRRT), in modalities such as Slow Continuous UltraFiltration (SCUF), Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous HemoDialysis (CVVHD), Continuous Veno-Venous HemoDiaFiltration (CVVHDF); to perform fluid management and reduction of uremic toxins. The Prismaflex HF1000/HF1400 set is indicated for use in patients with a body weight equal or greater than 30 kg (66lb).

TGA Public Summary