Baxter Oxiris Blood Purification Filter

INDICATIONS

The Oxiris set is indicated for use in critically ill patients with a body weight equal or greater than 30 kg (66lb) for hemoperfusion and / or renal replacement modalities such as:

• Slow Continuous UltraFiltration (SCUF)

• Continuous Veno-Venous Hemofiltration (CVVH)

• Continuous Veno-Venous HemoDialysis (CVVHD)

• Continuous Veno-Venous HemoDiaFiltration (CVVHDF)

When used for hemoperfusion only, the SCUF mode shall be used with no fluid removal prescription, as the indication is to reduce elevated levels of inflammatory mediators, such as cytokines, and to reduce endotoxins.

If patients suffer from acute kidney injury and / or volume overload, the Oxiris set is indicated for continuous renal replacement therapies (CRRT), to perform fluid management and removal of uremic toxins. The removal of inflammatory mediators and endotoxins is performed simultaneously when indicated for CRRT.

Intended Purpose

The Oxiris set is a single use device that provides blood purification via diffusion, convection and adsorption through a semipermeable membrane.

The Oxiris set is for use only in conjunction with the Prismaflex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).

All treatments administered with the Oxiris 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.

Important Risk Information 

The use of Oxiris set is contraindicated (as mentioned in the IFU) when:

• Patients present a known allergy to heparin or have type II thrombocytopenia caused by heparin (HIT Syndrome type II)

• A drug used simultaneously with Oxiris set is contraindicated per its Instructions for use

Relative contraindications (individual risk/benefit to be determined by treating physician) for the use of Oxiris include:

• The inability to establish vascular access to safely perform CRRT / hemoperfusion (SCUF; CVVH; CVVHD; CVVHDF)

• Severe hemodynamic instability

• Known hypersensitivity to any component of the Oxiris Set

This set is intended for use in the following veno-venous therapies: SCUF; CVVH; CVVHD; CVVHDF.
All treatments administered with the Oxiris 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.

For safe and proper use of the products mentioned herein, please refer to the Operator’s Manual or Instructions for Use.