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fresenius 2008t hemodialysis machine with bibag system
Fresenius Medical Care North America
Summary: The Fresenius 2008T Hemodialysis Machine with BiBag System is used for hemodialysis in patients with renal failure. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K121341 ↗
Decision Date
December 6, 2012
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Fresenius 2008T Hemodialysis Machine was cleared by the FDA via the 510k pathway on December 6, 2012. It is manufactured by Fresenius Medical Care North America and classified as a Class 2 device.
What It Is
The Fresenius 2008T Hemodialysis Machine is a medical device designed to perform hemodialysis, a process that filters and purifies the blood using a machine. This is necessary for patients whose kidneys are not functioning properly. The BiBag system is an integrated component that allows for the convenient use of bicarbonate cartridges, enhancing the efficiency and safety of the dialysis process.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients with end-stage renal disease (ESRD) or acute kidney injury (AKI) requiring renal replacement therapy. Nephrologists and dialysis nurses use it to manage and treat patients who need regular hemodialysis sessions. It is suitable for both chronic and acute dialysis settings, providing flexibility and reliability in patient care.
Indications for Use
The device is indicated for patients with renal failure who require hemodialysis to remove waste products and excess fluid from the blood. It is suitable for both chronic kidney disease and acute kidney injury patients who need dialysis support.
Practical Considerations
The Fresenius 2008T is compatible with a variety of dialysis access devices and can be used with different dialyzers. It is important to ensure proper setup and maintenance of the machine to prevent complications. The BiBag system simplifies bicarbonate management, reducing preparation time and potential for error.
Related Literature
The linked study investigated the use of the Seraph-100 Microbind Affinity Blood Filter in critically ill COVID-19 patients. The study involved four patients who received hemoperfusion therapy early in their illness. Although the study suggested potential benefits, it was limited by its small sample size and lack of a control group, making it difficult to draw definitive conclusions.
Frequently Asked Questions
What is the Fresenius 2008T Hemodialysis Machine used for?
It is used for performing hemodialysis in patients with renal failure to filter and purify their blood.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with renal failure requiring hemodialysis to remove waste and excess fluid from the blood.
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.