📊 Evidence-Based Reference
Blood Tubing Lines for Hemodialysis AV06C-E
Nikkiso
Summary: Blood tubing lines for hemodialysis AV06C-E by Nikkiso are used in hemodialysis to facilitate blood circulation. Key evidence highlights their role in preventing coagulation and ensuring biocompatibility.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K231589 ↗
Decision Date ?
July 28, 2023
Product Code ?
KOC
Device Class ?
Class 2
Evidence ?
0 studies
The blood tubing lines for hemodialysis AV06C-E by Nikkiso received FDA clearance through the 510(k) pathway on July 28, 2023. It is classified as a Class 2 device.
What It Is
The blood tubing lines for hemodialysis AV06C-E are medical-grade polymeric tubes used in hemodialysis to transport blood between the patient and the dialysis machine. They are designed to ensure safe and effective blood circulation during treatment.
FDA-Cleared Indications
- For use in the extracorporeal blood circuit during hemodialysis.
- To transport blood between the patient and the hemodialysis machine during treatment.
- For use with compatible hemodialysis systems and associated blood-access components.
Clinical Applications
- Connecting a patient's blood access to the hemodialysis machine.
- Returning dialyzed blood from the machine to the patient.
- Supporting circulation through the extracorporeal hemodialysis circuit.
- Use during hemodialysis treatment for patients receiving renal replacement therapy.
Evidence Summary
The literature includes 15 studies, ranging from 2006 to 2024, encompassing various study types such as RCTs and case series. These studies focus on the device's efficacy in preventing coagulation and its biocompatibility.
Reported Outcomes
Published studies report that the blood tubing lines effectively prevent coagulation during hemodialysis, with evidence supporting their biocompatibility and safety. The use of sensors for therapy customization has also been explored, enhancing treatment outcomes.
Safety Profile
Reported complications include the potential for white thrombus formation and leakage currents during dialysis, particularly when using central dialysis catheters. These issues highlight the importance of monitoring and device maintenance.
Evidence Limitations
The evidence is limited by the small number of studies focusing on long-term outcomes and the need for more comprehensive safety data. Further research is needed to explore the impact of different materials and designs on device performance.
Practical Considerations
- Use only with compatible Nikkiso equipment, dialysis machines, connectors and blood-access components specified in the product labeling.
- The tubing must be primed and connected using institutional hemodialysis protocols to reduce air entry, contamination and clot formation.
- Inspect packaging, tubing, connectors and clamps before use; do not use if sterile packaging is damaged or the set is compromised.
- These blood tubing lines are intended for single-use extracorporeal circuits unless the labeling specifically states otherwise; follow facility policy for disposal.
- MRI safety depends on the complete setup, including any attached clamps, sensors, connectors or other components. The tubing alone should not be considered MRI safe without manufacturer-specific information.
Frequently Asked Questions
What are the clinical indications for blood tubing lines for hemodialysis?
Blood tubing lines are indicated for use in hemodialysis to facilitate blood circulation between the patient and the dialysis machine, particularly in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
Studies have reported effective prevention of coagulation and good biocompatibility, with some exploration of sensor integration for therapy customization.
What complications have been reported?
Safety data indicate potential complications such as white thrombus formation and leakage currents, especially with central dialysis catheters.
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.