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seraflo tm bloodlines for hemodialysis
Cd Medical
Summary: Seraflo TM Bloodlines are used in hemodialysis for blood filtration. Key evidence highlights include safety concerns related to infections and device functionality.
FDA Clearance Information
Pathway
510K
Number
K864784 ↗
Decision Date
January 20, 1987
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Seraflo TM Bloodlines were cleared through the FDA 510(k) pathway on January 20, 1987, by Cd Medical. It is classified as a Class 2 medical device.
What It Is
The Seraflo TM Bloodlines are components used in hemodialysis systems to facilitate blood filtration and purification. They are intended for use in patients requiring dialysis due to renal failure.
Clinical Applications
These bloodlines are commonly used in clinical settings for patients undergoing hemodialysis, particularly in hospital-based dialysis centers. They are integral to the dialysis process, ensuring safe and effective blood filtration.
Evidence Summary
The available literature includes two studies, a case-control study from 1999 and an unknown type from 1995, focusing on safety and infection risks associated with dialysis practices.
Reported Outcomes
Published studies report outcomes such as Enterobacter cloacae bloodstream infections and pyrogenic reactions in hemodialysis patients. These outcomes were linked to equipment and procedural issues in dialysis centers.
Safety Profile
Reported complications include bloodstream infections and pyrogenic reactions, primarily due to dysfunctional check valves and backflow from contaminated dialysis machine units.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on specific infection cases. Further research is needed to explore broader safety and efficacy outcomes in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Seraflo TM Bloodlines?
The clinical indications are detailed in the FDA documentation, primarily for use in hemodialysis procedures.
What outcomes have been reported in clinical studies?
Clinical studies have reported outcomes such as Enterobacter cloacae bloodstream infections and pyrogenic reactions.
What complications have been reported?
Safety data indicate complications including bloodstream infections and pyrogenic reactions linked to equipment issues.
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.