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allient sorbent hemodialysis system model 1000
Renal Solutions
Summary: The Allient Sorbent Hemodialysis System Model 1000 is a dialysis device used for renal replacement therapy. It is primarily used by nephrologists in clinical settings for patients with kidney failure.
FDA Clearance Information
Pathway
510K
Number
K043574 ↗
Decision Date
June 3, 2005
Product Code
FKT
Device Class
Class 2
Evidence
0 studies
The Allient Sorbent Hemodialysis System Model 1000 was cleared by the FDA through the 510k pathway on June 3, 2005. It is manufactured by Renal Solutions and classified as a Class 2 medical device.
What It Is
The Allient Sorbent Hemodialysis System is a medical device designed for hemodialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It utilizes sorbent technology to purify dialysate, which can be particularly useful in settings where water supply is limited. This system is portable, making it suitable for use in various environments, including hospitals and potentially in field settings.
Clinical Applications
This device is commonly used in nephrology for patients requiring renal replacement therapy due to acute or chronic kidney failure. It is particularly beneficial in settings where traditional dialysis resources are limited, such as in disaster relief scenarios or in remote locations. The portability of the system allows for flexibility in treatment locations, making it a valuable tool for both inpatient and outpatient care.
Indications for Use
The Allient Sorbent Hemodialysis System is indicated for use in patients who require dialysis due to kidney failure. It is suitable for patients with acute kidney injury or chronic kidney disease who need regular dialysis sessions to manage waste and fluid balance.
Practical Considerations
The system's portability makes it ideal for use in non-traditional settings, but clinicians should be aware of the need for proper anticoagulation management, especially when using citrate. Compatibility with existing dialysis protocols should be confirmed, and training on the specific operation of the device is recommended.
Related Literature
The linked study investigated the use of a Selective Cytopheretic Inhibitory Device (SCD) with regional citrate anticoagulation in conjunction with a portable sorbent dialysis system. It highlighted the potential for this combination to be used in critical care settings, such as for patients with severe sepsis and acute kidney injury. The study noted the challenge of citrate interference with sorbent dialysis, which requires careful management. Limitations include the need for further research to confirm efficacy and safety in diverse clinical scenarios.
Frequently Asked Questions
What is the Allient Sorbent Hemodialysis System used for?
It is used for providing dialysis treatment to patients with kidney failure, particularly in settings where traditional dialysis resources are limited.
What specialties typically use this device?
Nephrologists and healthcare professionals in renal care settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients who require dialysis due to kidney failure, including those with acute kidney injury or chronic kidney disease.
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.