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affinity pixie oxygenation system with carmeda bioactive surface balance biosuface
Medtronic
Summary: The Affinity Pixie Oxygenation System is a medical device used for oxygenating blood during cardiopulmonary bypass procedures, primarily in neonatal and pediatric patients. It is utilized by cardiac surgeons and perfusionists in specialized surgical settings.
FDA Clearance Information
Pathway
510K
Number
K141233 ↗
Decision Date
June 12, 2014
Product Code
DTN
Device Class
Class 2
Evidence
0 studies
The Affinity Pixie Oxygenation System was cleared through the FDA 510(k) pathway on June 12, 2014. It is manufactured by Medtronic and classified as a Class II medical device under product code DTN.
What It Is
The Affinity Pixie Oxygenation System is a compact oxygenator designed for use in cardiopulmonary bypass procedures. It features the Carmeda BioActive Surface, which enhances biocompatibility by reducing blood activation and clotting. The system is rated for blood flow rates between 0.1 L/min and 2 L/min, making it suitable for the delicate physiology of neonatal and pediatric patients.
Clinical Applications
This device is commonly used in pediatric cardiac surgery, particularly for infants and neonates undergoing open-heart procedures. It is employed in settings such as children's hospitals and specialized cardiac centers. The device is crucial for maintaining adequate oxygenation and perfusion during surgeries that require cardiopulmonary bypass.
Indications for Use
The Affinity Pixie Oxygenation System is indicated for use in patients requiring cardiopulmonary bypass, specifically targeting neonatal and pediatric populations who need precise oxygenation and perfusion support during cardiac surgery.
Practical Considerations
The device is designed to accommodate the smaller blood volumes and higher cardiac indexes typical in pediatric patients. It is compatible with standard cardiopulmonary bypass equipment and requires careful monitoring of flow rates and oxygenation levels during use.
Related Literature
The linked study evaluated the Affinity Pixie Oxygenation System in pediatric and infant patients at Great Ormond Street Children's Hospital. The study found that the system effectively supported higher cardiac indexes than previously anticipated in neonatal and pediatric patients. However, the study was limited to a single center and may not reflect broader clinical experiences.
Frequently Asked Questions
What is the Affinity Pixie Oxygenation System used for?
It is used for oxygenating blood during cardiopulmonary bypass procedures in neonatal and pediatric patients.
What specialties typically use this device?
Pediatric cardiac surgery, particularly in specialized children's hospitals and cardiac centers.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures for neonatal and pediatric patients requiring oxygenation and perfusion support 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.