📋 FDA Reference
Modification of Maxima Forte Hollow Fiber Oxygenator with Balance Biocompatible Surface with Plasma Resistent Fiber M0
Medtronic Vascular
Summary: The Maxima Forte Hollow Fiber Oxygenator with Balance Biocompatible Surface is used in cardiopulmonary bypass procedures to oxygenate blood. It is primarily used by cardiac surgeons and perfusionists during open-heart surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K984271 ↗
Decision Date ?
March 9, 1999
Product Code ?
DTZ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on March 9, 1999, by Medtronic Vascular. It is classified as a Class 2 medical device under product code DTZ.
What It Is
The Maxima Forte Oxygenator is a medical device designed to oxygenate and remove carbon dioxide from the blood during cardiopulmonary bypass procedures. It features a hollow fiber design with a plasma-resistant fiber and a biocompatible surface to minimize blood damage and inflammatory responses. This device is crucial in maintaining appropriate blood gas levels during complex cardiac surgeries.
FDA-Cleared Indications
- Use during cardiac surgical procedures requiring cardiopulmonary bypass.
- Temporary extracorporeal oxygenation and carbon dioxide removal during cardiopulmonary bypass.
- Use with a compatible cardiopulmonary bypass circuit under the direction of trained cardiac surgical and perfusion personnel.
Clinical Applications
- Cardiopulmonary bypass during coronary artery bypass grafting.
- Cardiopulmonary bypass during heart valve repair or replacement.
- Temporary blood oxygenation and carbon dioxide removal while the heart is stopped or cardiac function is supported during surgery.
- Use in an operating-room heart-lung machine circuit for cardiac procedures requiring extracorporeal circulation.
Practical Considerations
- The oxygenator is intended for temporary intraoperative use, not long-term extracorporeal life support or chronic respiratory support.
- Select the appropriate oxygenator size and blood-flow capacity for the patient's body size and planned bypass flow; follow the current manufacturer instructions for use.
- It must be properly primed, de-aired, connected, and monitored as part of a compatible cardiopulmonary bypass circuit to reduce the risk of air embolism, inadequate gas exchange, or blood trauma.
- The device contains blood-contacting polymeric components and is not an implanted device; MRI safety should not be assumed and is generally not relevant during its operating-room use.
- Potential complications relate to cardiopulmonary bypass and extracorporeal circulation, including bleeding, clotting, hemolysis, inflammatory reactions, air embolism, inadequate oxygenation, and device or circuit malfunction.
Frequently Asked Questions
What is Maxima Forte Oxygenator used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in the field of cardiovascular surgery.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures requiring temporary blood oxygenation and carbon dioxide removal.
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.