đź“‹ FDA Reference
Affinity Cp Centrifugal Blood Pump with Balance Biosurface
Summary: The Affinity CP Centrifugal Blood Pump is a medical device used in extracorporeal circulation during cardiac surgery. It is primarily utilized by cardiac surgeons and perfusionists to support blood flow.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111657 ↗
Decision Date ?
June 23, 2011
Product Code ?
KFM
Device Class ?
Class 2
Evidence ?
0 studies
The Affinity CP Centrifugal Blood Pump by Medtronic was cleared through the FDA 510(k) pathway on June 23, 2011. It is a Class 2 device under product code KFM.
What It Is
The Affinity CP Centrifugal Blood Pump is a device designed to support extracorporeal circulation by pumping blood outside the body during cardiac surgery. It utilizes centrifugal force to move blood, minimizing shear stress and reducing the risk of hemolysis. The Balance Biosurface technology is incorporated to enhance biocompatibility and reduce inflammatory responses.
FDA-Cleared Indications
- Use during extracorporeal circulation for cardiac surgery.
- Support blood circulation as part of a cardiopulmonary bypass circuit.
- Use with compatible extracorporeal circuit components according to the device labeling and institutional protocols.
Clinical Applications
- Blood pumping during cardiopulmonary bypass for open cardiac surgery.
- Circulatory support while the heart is stopped or temporarily unable to provide adequate circulation during surgery.
- Use in extracorporeal circuits assembled and operated by trained cardiac surgery and perfusion personnel.
Practical Considerations
- The pump is used with a compatible extracorporeal circuit and other bypass components; clinicians must verify circuit and connector compatibility before use.
- The pump is available in configurations or sizes intended to accommodate different flow requirements and patient populations; selection should follow the manufacturer’s instructions and perfusion protocol.
- It requires trained perfusion personnel for priming, setup, operation, monitoring, and troubleshooting.
- It is an external blood-contacting pump, not an implanted device. MRI safety should be determined for the complete circuit and any connected components; the pump should not be taken into an MRI environment unless the labeling specifically permits it.
- Use requires assessment of patient-specific risks associated with cardiopulmonary bypass, including bleeding, thrombosis, air embolism, hemolysis, infection, and inflammatory responses.
Related Literature
The linked study compared the hemolysis effects of a magnetic levitation pump and a constrained vortex pump during minimally invasive extracorporeal circulation. It found that elevated plasma free hemoglobin, which can lead to multi-organ injury, was reduced with minimally invasive technologies. However, the study was a pilot and may have limitations in sample size and generalizability.
Frequently Asked Questions
What is the Affinity CP Centrifugal Blood Pump used for?
It is used for extracorporeal circulation during cardiac surgery to support blood flow and oxygenation.
What specialties typically use this device?
Cardiac surgeons and perfusionists in cardiac surgery settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring extracorporeal circulation during cardiac surgery.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.