Use of the SCD-PED as a standalone unit to provide any renal replacement therapy or fluid and electrolyte management therapy is contraindicated. The SCD-PED cartridge and SCD Blood Tubing Set should not be used on patients who have a known allergy to any of the components in this product.

1. Carefully read all warnings, precautions, and instructions before use. Follow all operating, maintenance, and installation procedures as described in this document.
2. The blood flow path in the SCD-PED is non-sterile.
3. Operating procedures are to be performed only by trained and qualified clinicians/personnel.
4. The target post-SCD ionized calcium level during SCD-PED therapy is less than 0.40 mmol/L.
5. The CKRT device and disposables must be operated by trained personnel according to the instructions for use provided by the manufacturer.
6. The use of anything other than the SCD Blood Tubing Set provided by SeaStar Medical may result in patient injury.
7. Do not modify the SCD-PED Cartridge or the SCD Blood Tubing Set in any way.
8. Carefully inspect barriers of all items prior to use. Do not use item if barrier is damaged.
9. The SCD-PED Cartridge and SCD Blood Tubing Set are single use sets. Do not sterilize or reuse the SCD-PED Cartridge. Do not re-sterilize or reuse the SCD Blood Tubing Set.
10. Log or note the lot number of the SCD-PED Cartridge(s) used on a patient in that patient’s Electronic Medical Record (EMR) for tracking purposes.
11. During the prime and operation procedures, observe closely for blood/fluid leakage at all circuit connections. If tightening the connections does not stop leakage, immediately replace the SCD-PED Cartridge and the SCD Blood Tubing Set. Leakage can cause blood loss or air entry/air embolism. 
12. To prevent contamination, the SCD-PED Cartridge and the SCD Blood Tubing Set must be connected and primed using aseptic technique immediately after opening the packaging and removing caps to make the connections. Use aseptic technique when handling all connections and replacing the SCD-PED Cartridge and the SCD Blood Tubing Set. Universal precautions should be followed to ensure the safety of the patient and clinician.
13. In the event that a patient decompensates (per the treating physician’s clinical judgment) within 2 hours of a new SCD-PED Cartridge initiation, SCD-PED therapy should be terminated, and a blood sample should be obtained from the patient and cultured for aerobic, anaerobic, and fungal organisms.
14. Store the SCD-PED Cartridge in a dry place, between 5 °C (41 °F) and 30 °C (86 °F). The upper limit for the SCD Blood Tubing Set is 50 °C (122 °F), with no lower limit specified. 

1. Used SCD-PED Cartridges and SCD Blood Tubing Sets are considered biohazardous materials. Handle and dispose in accordance with hospital policy/procedure and applicable local, state, and federal laws and regulations.
2. Carefully inspect the SCD-PED Cartridge and the SCD Blood Tubing Set prior to use. Do not use the SCD-PED Cartridge and/or the SCD Blood Tubing Set if the package is damaged or if the lines are kinked, or if there is any visual evidence of cracks, breakage, or contamination.
3. The CKRT circuit with SCD-PED Cartridge and SCD Blood Tubing Set connected must be anticoagulated with a continuous citrate infusion during SCD-PED therapy.
4. Prevent entry of air into the SCD-PED Cartridge or the SCD Blood Tubing Set during set up and priming.
5. Use of SCD-PED with dialysis modalities other than CKRT (i.e., intermittent hemodialysis or peritoneal dialysis) has not been studied. 

Five adverse reactions were observed in more than one instance across the two pediatric SCD studies (SCD-PED-01 [16 subjects enrolled] and SCD-PED-02 [6 subjects enrolled]). Those adverse reactions include six instances of hypotension across three subjects, four instances of hypothermia across two subjects, four instances of tachycardia across three subjects, two instances of hyperglycemia across two subjects, and two instances of thrombocytopenia across two subjects.