CytoSorbTM 300 mL Device – Instructions For Use English

1. Introduction 1.7. Air entering the extracorporeal circuit during treatment can result in serious 2.4. Install the arterial and venous bloodlines on the blood pump.
1.1. Intended Use injury or death. Check the integrity of all bloodlines and connections prior to Note: Refer to the manufacturer’s instructions for use that were included with
the initiation of blood perfusion and periodically during the treatment. The the blood tubing set or blood pump.
The CytoSorb Device (CytoSorb) is a non-pyrogenic, sterile, single-use device venous return line or drip chamber should be continuously monitored with an
designed to remove cytokines. CytoSorb contains adsorbent polymer beads 2.5. Aseptically spike 0.9% Sterile Normal Saline with a clamped IV
air detector. administration set. Attach the IV administration set to the patient end of the
that adsorb cytokines as blood passes through the device. CytoSorb is placed
in a blood pump circuit. 1.8. CytoSorb should only be used as directed by a physician. arterial bloodlines.
1.9. Side Effects 2.6. Open the clamp on the IV set. Prime the arterial bloodline using a blood pump
1.2. Indications
speed of approximately 150 mL/min. Refer to the pump’s manual.
CytoSorb is indicated for use in conditions where excessive cytokine levels In rare cases, hypersensitivity reactions may occur during extracorporeal
Note: If air bubbles are observed within the outlet of the device, gently thump
exist. treatment. A history of allergies (polystyrene/divinylbenzene, polycarbonate,
the outlet side of the device with the palm of your hand during priming to
polypropylene, silicone and polyester) is an indication requiring careful
Results from current studies suggest that CytoSorb may be used 6 hours per remove them.
monitoring for hypersensitivity reactions. In the event of a hypersensitivity
day, for up to 7 consecutive days. reaction, treatment must be discontinued and aggressive, first line therapy for 2.7. Stop the blood pump. Clamping the line, remove the inlet port plug of
Acceptable Blood Flow Rate: 200-400 mL/min analphylactoid reaction must be initiated. The decision to return the blood to CytoSorb and connect the primed arterial bloodline to the inlet port. DO NOT
Optimum Blood Flow Rate: 250-400 mL /min the patient encountering a hypersensitivity reaction must be made by a remove the outlet port plug at this time.
1.3. Contraindications physician. The patient should also be monitored for other clinical events CAUTION: Avoid the entry of air into CytoSorb.
associated with extracorporeal treatment, including but not limited to 2.8. Turn CytoSorb so the inlet end is facing downward. Remove CytoSorb outlet
Patients that are Heparin Induced Thrombocytopenia (HIT) positive and
hypotension, change in body temperature, feeling of coldness, muscle port plug and attach the venous line.
citrate regional anticoagulation is unavailable as an alternative anticoagulation
cramping, headache, nausea, vomiting, fever, or pruitis. 2.9. Turn on the blood pump and prime the venous line at approximately 150
method.
1.10. Limitations mL/min.
Patients with very low platelet counts (< 20,000/L).
This device is intended for use on persons 18 – 80 years old. 2.10. Turn the blood pump off.
1.4. Relative Contraindications
Note: Discretion should be used when treating a patient weighing less than CAUTION: Verify that the circuit connections to CytoSorb are as shown in
Patients in acute sickle cell crisis. 100 lb. (45 kg). Blood flow rate should be adjusted to reduce the risk of an the illustration (on reverse). DO NOT kink any of the blood lines.
Patients concurrently requiring immunosuppressive therapy, with the adverse effect. 2.11. Complete priming the extracorporeal circuit at a blood pump speed of
exception of corticosteroids, or who are profoundly immune suppressed (e.g. This device is not to be used for more than one treatment. approximately 150 mL/min with a minimum of 2 L of normal saline.
CD4 < 200 or neutropenia with ANC < 1,000/L) CytoSorb is a single-use device. 2.12. When renal replacement therapy (dialysis, hemofiltration) is required,
Patients who are or may be pregnant. CytoSorb must be stored/used within the temperature range of 1 – 40ºC. CytoSorb shall be placed upstream (proximal) of the dialysis device. An
1.5. Precautions accessory bloodline between CytoSorb and the dialysis device is required.
2. Preparation for Treatment Priming will require 2L of normal saline, and anticoagulation requirements
CytoSorb should only be administered by personnel who have been 2.1. CytoSorb is intended for use with standard, commercially available bloodlines may need to be increased for the dual devices.
properly trained in administration of extracorporeal therapies. compatible with the pump system used. Female Luer connectors are required 3. Initiation of Treatment
The extracorporeal circuit should be monitored continuously during to connect with CytoSorb blood ports. The roller blood pump should be
3.1. Anticoagulation
treatment for blood leaks. In the event of a blood leak during treatment, the capable of delivering up to 400 mL/min blood flow rate.
health care provider should respond according to the facility’s established Heparin: Patient shall be anticoagulated to an ACT of 160 – 210 seconds or
CAUTION: Pressure monitoring of the bloodline between the blood pump an aPTT of 60 – 80 seconds prior to the start of treatment. Clinicians shall
protocols. and the CytoSorb device is recommended. If the pump system is not equipped monitor and maintain these levels throughout the treatment.
1.6. CytoSorb may be capable of removing drugs (i.e. antibiotics, pressor agents, with a pressure sensing device for this line, use of an accessory pressure
etc.) similar to dialysis. The physician is advised to measure concomitant drug Citrate: When using regional anticoagulation, a dialyzer or hemofilter shall
monitoring device is recommended.
concentrations, where a test exists, after CytoSorb treatment and adjust drug be used downstream of CytoSorb to remove calcium citrate complexes.
2.2. The fluid pathway in an intact device inside the protective pouch is sterile.
dosing accordingly. In addition, when nutritional supplementation is indicated, 3.2. If being used with a dialysis device, initiate treatment as directed by the
Inspect the protective pouch for any sign of damage to the CytoSorb device. Instructions For Use included with the hemodialyzer.
the physician is encouraged to administer gastric or other internal tube feeding Carefully remove CytoSorb from the pouch and examine for defects.
rather than total parenteral intravenous nutrition and lipids. Lipid or fat 4. During Treatment
emulsions may negatively affect CytoSorb. If lipids (e.g. Lipovena), fat CAUTION: DO NOT USE CytoSorb if it appears to be damaged. DO NOT
4.1. Monitor the pressure in the extracorporeal circuit, including the line between
emulsions or TPN-containing lipids are required or clinically indicated, then USE CytoSorb if beads appear to be free-floating within the endcaps.
the blood pump and CytoSorb, if available. Investigate any indication of
the physician is advised to administer these after CytoSorb treatment is 2.3. Locate the inlet (arterial) end of the device. With the inlet end of the device abnormal pressure.
completed or discontinue administration two (2) hours prior to the next facing downward, firmly secure CytoSorb in a vertical position to the pump 4.2. Visually inspect the CytoSorb for any signs of clotting or blood leaks from the
CytoSorb treatment. system’s device holding pole (or alternate device holding system) using a circuit or within the dialyzer. Report all clotting or blood leaks to the
standard dialyzer clamp. Leave the port plugs in place, and rotate CytoSorb responsible medical professional.
into a horizontal position.
4.3. Periodically monitor the extracorporeal circuit for evidence of obstruction,
security of fittings, and air within the circuit.

CytoSorbents Inc. ● 7 Deer Park Drive, Suite K ● Monmouth Junction, NJ 08852 USA ● Phone: (732) 329-8885 ● Fax: (732) 329-8650
Part #17-0071-09 Issued: May 18, 2012 Page 1 of 2
 CytoSorbTM 300 mL Device – Instructions For Use English

5. Termination of Treatment CytoSorb in Stand-Alone Configuration

5.1. When the treatment is completed, terminate the treatment as directed by the
EXPLANATION OF SYMBOLS
Instructions For Use included with bloodlines and blood pump.
5.2. Discard the bloodlines and CytoSorb in an appropriate biohazard waste LOT = Batch Code
receptacle.

CytoSorb
CAUTION: Reuse of CytoSorb may result in secondary infection, device
clotting and/or a biohazardous situation.
SN = Serial Number

6. Performance Characteristics
Blood Priming Volume: 120 mL STERILE R = Fluid Path Sterilized using Irradiation
P
Flow Resistance (Qb < 500 mL/min): 300 mmHg
Maximum Blood Flow Rate: 400 mL/min
Maximum Pressure Limit:
Storage Fluid:
500 mm Hg
Isotonic Saline
Blood Pump
Pressure Sensor P

Venous Drip Chamber

2 = Do Not Reuse

Priming Fluid: Physiologic Saline Air Detector

Arterial
Sterilization: Gamma Irradiation
7. Blood Contact Materials ! = Caution, Consult Accompanying Documents

P Pressure Sensor
Adsorbent Material: Crosslinked Divinylbenzene/polyvinylpyrrolidone
Venous
Housing: Polycarbonate = Use By YYYY-MM-DD
O-ring Seals: Silicone
Screen: Polyester/Polypropylene
8. Accessories
CytoSorb and Dialyser in Combination Configuration = Do Not Use if Packaging is Damaged
When treating with CytoSorb and a dialyzer/hemofilter simultaneously, a
Female-Female Luer Lock Connector is required to connect CytoSorb to the
dialyzer/hemofilter.
9. European Authorized Representative = European Conformity
MedPass International Limited
Company #3628305
Windsor House, Barnett Way = Manufacturer

Dialyser
Barnwood, Gloucester GL4 3RT
United Kingdom
Ph: +44(0) 1 452 619 22 EC REP = European Authorized Representative
Email: MedPass.AR@MedPass.org

CytoSorb
10. Certifications

Blood Pump
Pressure Sensor P

0344 Venous Drip Chamber

Air Detector
Arterial

P Pressure Sensor

Arterial Drip
Chamber
Venous

CytoSorbents Inc. ● 7 Deer Park Drive, Suite K ● Monmouth Junction, NJ 08852 USA ● Phone: (732) 329-8885 ● Fax: (732) 329-8650
Part #17-0071-09 Issued: May 18, 2012 Page 2 of 2