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maxima filtered hardshell reservoir
Medtronic Vascular
Summary: The Maxima Filtered Hardshell Reservoir is a medical device used in cardiopulmonary bypass procedures to filter air and debris from venous blood. It is primarily used by cardiac surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K932254 ↗
Decision Date
August 3, 1993
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Maxima Filtered Hardshell Reservoir by Medtronic was cleared via the FDA 510(k) pathway on August 3, 1993. It is classified as a Class III device under product code DTB.
What It Is
The Maxima Filtered Hardshell Reservoir is a component used in cardiopulmonary bypass circuits. It functions to collect and filter venous blood, removing air bubbles and particulate matter before the blood is returned to the body. This device is crucial in maintaining blood integrity and preventing air embolism during cardiac surgeries.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures requiring cardiopulmonary bypass, such as coronary artery bypass grafting or valve replacements. It is utilized by cardiac surgeons and perfusionists to ensure safe and efficient blood management. Patients undergoing complex cardiac procedures are typical candidates for its use.
Indications for Use
The FDA indications suggest that this device is intended for use in filtering venous blood during cardiopulmonary bypass procedures. It is designed to prevent air embolism and remove debris, making it suitable for patients undergoing heart surgery.
Practical Considerations
The Maxima Filtered Hardshell Reservoir is compatible with standard cardiopulmonary bypass circuits. Clinicians should be aware of its volume capacity and flow rate limits to prevent bubble formation. Proper priming and handling techniques are essential for optimal performance.
Related Literature
The linked study investigated bubble formation and air filtration capabilities of the Maxima Hardshell Reservoir. It found that bubbles formed at low volumes and high flow rates, and were not completely removed by membrane oxygenators and arterial line filters. The study highlighted the importance of monitoring and managing flow conditions to minimize air embolism risk. Limitations include its focus on specific flow conditions and device comparisons.
Frequently Asked Questions
What is the Maxima Filtered Hardshell Reservoir used for?
It is used to filter air and debris from venous blood during cardiopulmonary bypass procedures in cardiac surgery.
What specialties typically use this device?
Cardiac surgeons and perfusionists in operating rooms during heart surgeries.
What are the FDA-cleared indications?
The device is indicated for filtering venous blood to prevent air embolism and remove debris during cardiopulmonary bypass.
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.