Intended Use
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 • Therapeutic plasma exchange with a secondary plasma device • Red blood cell exchange, depletion, and depletion/exchange • Mononuclear cell collection from the peripheral blood • Granulocyte collection from the peripheral blood • White blood cell depletion • Platelet depletion • Processing of harvested bone marrow
*Procedure availability varies by country.
Contraindications:
Contraindications for the Spectra Optia system 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.
Possible adverse events of apheresis procedures 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 failure, air embolism, blood loss/anemia, electrical shock, fluid imbalance, inadequate separation of blood components.
Reactions to transfused blood products 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.
Restricted to prescription use only:
Operators must be familiar with the system's operating instructions.
Procedures must be performed by qualified medical personnel.
The operator should refer to the Spectra Optia operator's manual for the full indications for use/contraindications and warnings.