Adverse Effects - Medtronic Affinity NT CB511 Mode D'emploi

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Monitoring of preoxygenator circuit pressure should be considered.
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The blood phase pressure must be greater than the gas phase pressure at all times in the oxygenator.
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Do not exceed blood phase pressure of 750 mmHg.
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Do not exceed heat exchanger water phase pressure of 206.8 kPa (30 psi).
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Heat exchanger water temperature shall not exceed 42°C (107°F).
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Follow institution CPB protocol when using disinfectants in the heater/cooler during bypass. The integrity of
the water path has been verified with hydrogen peroxide (330 ppm). Contact Medtronic for information
regarding the use of additional disinfectants.
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Band all tubing connections for added protection against high fluid pressures.
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A replacement oxygenator should be readily available during perfusion.
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Do not obstruct gas outlet vents to prevent the gas side pressures from exceeding blood side pressures.
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Only persons thoroughly trained in CPB procedures should use this device. Operation of each device
requires constant supervision by qualified personnel for patient safety. Perfusion must be carefully and
constantly monitored.
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Each device is intended for single use only. Do not reuse or resterilize. Sterilized using ethylene oxide.
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Attach tubing in such a manner as to prevent kinks or restrictions that may alter blood, water, or gas flow.
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Do not allow alcohol, alcohol-based fluids, anesthetic liquids (such as isoflurane), or corrosive solvents
(such as acetone) to come into contact with the device as they may jeopardize the structural integrity.
6. Precautions
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This device was designed for single patient use only. Do not reuse, reprocess, or resterilize any component
of the system. 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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Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
Adequate anticoagulation must be maintained before and during bypass.
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Additional warnings and precautions applicable to specific procedures can be found at appropriate places in
the instructions for use.
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It is the responsibility of the user to dispose of the devices in accordance with local regulations and hospital
procedures.

7. Adverse effects

The following known adverse effects are associated with the use of the product: blood loss, coagulopathy,
death, embolism, excessive blood component activation or thrombogenicity, exsanguination, hemolysis,
hemolytic anemia, hypercarbia, hypotension, hypovolemia, hypoxia, infection, ischemia, neurological
dysfunction, and organ dysfunction.
8. Information for products with Cortiva bioactive surface
The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated
surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva
bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa
Caution: Product coated with Cortiva bioactive surface is intended for single use only. Resterilization may
adversely affect the Cortiva bioactive surface.
Caution: Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
1 Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.
8 Instructions for Use English
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