Clinical Benefits; Risks And Side Effects - Eurosets COLIBRI SYSTEM Instructions For Use Manual

1.9. CLINICAL BENEFITS

COLIBRÌ System contributes to achieve the following potential clinical benefits:
•
improve survival rate respect the conventional (and/or medical) therapy;
•
allow to perform CPB procedure.
1.10.

RISKS AND SIDE EFFECTS

Possible risks and side effects include but are not limited to:
•
Adverse reaction of the blood or the tissues to the extracorporeal perfusion system (e.g. activation of the
coagulation system, inflammatory response, SIRS, thrombocytopenia, platelet dysfunction, disseminated
intravascular coagulation, Allergic reaction, Anaphylactic shock, Systemic Toxic effects);
•
Bleeding/Haemorrhage;
•
Environmental damage (e.g. electromagnetic interference, fire, user contamination);
•
Excessive blood flow: injury to circulatory system, hyperoxia;
•
Haemodilution;
•
Haemolysis (anemia, thrombosis, hypertension, stroke, shock);
•
Hyperthermia;
•
Hypovolemia;
•
Hypotension;
•
Infection/sepsis;
•
Insufficient blood flow: insufficient oxygenation of blood (hypoxia, hypoxemia, brain injury, metabolic
acidosis), insufficient CO2 removal (respiratory acidosis, hypercapnia), hypothermia;
•
Stroke/CVA (ischemic/hemorrhagic);
•
Thrombosis / thromboembolism.
These are the potential side effects of all extracorporeal blood circulation systems.
Warning
Any serious incident occurring in relation to the device should be reported to the manufacturer
and the competent authority of the Member State in which the user and/or patient is established.
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