Therapeutic Plasma Exchange Patient Safety

Contraindications
Contraindications for the use of Spectra Optia are limited to those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure and those associated with all types of automated apheresis systems.

Adverse events of apheresis procedures can include
Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, allergic reactions, infection, hemolysis, thrombosis in patient and device, hypocalcemia, hypokalemia, thrombocytopenia, hypoalbuminemia, anemia, coagulopathy, fatigue, hypomagnesemia, hypogammaglobulinemia, adverse tissue reaction, device failure/disposable set failure, air embolism, blood loss/anemia, electrical shock, fluid imbalance, and inadequate separation of blood components.

Reactions to blood products transfused during procedures can include
Hemolytic transfusion reaction, immune-mediated platelet destruction, fever, allergic reactions, anaphylaxis, transfusion-related acute lung injury (TRALI), alloimmunization, posttransfusion purpura (PTP), transfusion-associated graft-versus-host disease (TA-GVHD), circulatory overload, hypothermia, metabolic complications and transmission of infectious diseases and bacteria.^3-4

Restricted to prescription use only

• Operators must be familiar with the system's operating instructions.
• Procedures must be performed by qualified medical personnel.

The Spectra Optia Apheresis System, a blood component separator, may be used to perform the following therapeutic apheresis, cell collection, and cell processing procedures: Therapeutic plasma exchange; red blood cell exchange, depletion, and depletion/exchange for the transfusion management of sickle cell disease in adults and children; mononuclear cell collection from the peripheral blood; granulocyte collection from the peripheral blood; white blood cell reduction for patients with leukocytosis at risk for leukostasis; and processing of harvested bone marrow for the purpose of facilitating hematopoietic reconstitution.