Adverse Effects - Medtronic Affinity Fusion BB811 Instrucciones De Uso

Note: The oxygenator water inlet, water outlet, and gas outlet ports do not have protective caps.
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All gas emboli must be cleared from the extracorporeal circuit before initiating bypass. Gas emboli
are hazardous to the patient.
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If air leaks are observed during priming and/or operation, this may result in air embolism to the
patient and/or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the
device if these conditions are observed.
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In any extracorporeal circuit, the use of a pre-bypass and arterial filter is recommended.
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Monitoring of circuit pressure is recommended.
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The blood phase pressure should be greater than the gas phase pressure at all times in the
oxygenator.
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The oxygenator should not be operated outside the recommended parameter ranges.
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Do not exceed blood pressure of 100 kPa (750 mm Hg) in the blood pathway of the oxygenator.
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Once an oxygenator is primed with blood, adequate heparinization should be maintained per
institution cardiopulmonary bypass (CPB) protocol and the blood pathway should be constantly
recirculated within the recommended blood flow range.
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After initiation of bypass, blood flow should circulate through the oxygenator at all times within the
recommended blood flow range during cardiopulmonary bypass, except during emergency
oxygenator replacement.
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Heat exchanger temperature should not exceed 42°C.
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Disinfectants must not be used in the heater/cooler system while the heat exchanger is in use; if
disinfectants have been used in the heater/cooler system, the system must be thoroughly flushed
prior to use.
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It is recommended to band all blood tubing connectors for added protection against disconnection.
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Ensure that unused ports remain capped to prevent contamination and that the caps are tightened
to avoid leakage.
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A replacement oxygenator should be readily available during CPB.
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Do not obstruct gas outlet vents to prevent gas-side pressures from exceeding blood-side
pressures.
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Gas transfer characteristics of the oxygenator are not significantly affected by concentrations of
isoflurane anesthetic gas up to 1.3% and sevoflurane anesthetic gas up to 2.6%. Above these
concentrations, adjustments of FiO
transfer performance.
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Gas transfer rates may change over time and adjustments of FiO
needed to achieve desired gas transfer performance.
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Ensure that the venous reservoir outlet is always positioned above the highest point of the blood
inlet of the oxygenator.
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Tubing should be attached in such a manner as to prevent kinks or restrictions that may alter the
blood, water, or gas flow.
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Do not allow alcohol, alcohol-based fluid, anesthetic liquids (such as isoflurane), or corrosive
solvents (such as acetone) to come in contact with the device as they may jeopardize its structural
integrity.
7. Precautions
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Refer to package labeling for storage temperature requirements.
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This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this
product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the
device and/or create a risk of contamination of the device which could result in patient injury, illness,
or death.
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Use aseptic technique in all procedures.
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Use of a gas scavenging system during transfer of anesthetic gas through the oxygenator should
be considered.
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Dispose of the devices in accordance with local hospital, administrative, and/or other government
policies.

8. Adverse Effects

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Possible side effects include, but are not limited to, hypoxia or hypercarbia, air embolism and
thromboembolic phenomena, blood loss, hemolysis, platelet dysfunction, renal compromise,
circulatory compromise, hypothermia or hyperthermia, activation (coagulation/complement),
hypotension, and death.
and gas flow rates may be needed to achieve desired gas
2
and gas flow rates may be
2
Instructions for Use English 23