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Hemodialysis Venous Blood Tubing Set or Similar Trade Name
National Medical Care
Summary: The hemodialysis venous blood tubing set by National Medical Care is used in dialysis procedures to transport blood. Key evidence highlights include issues with tubing kinks leading to hemolysis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K971687 ↗
Decision Date ?
July 29, 1997
Product Code ?
FJK
Device Class ?
Class 2
Evidence ?
0 studies
The hemodialysis venous blood tubing set was cleared by the FDA via the 510(k) pathway on July 29, 1997. It is manufactured by National Medical Care and classified as a Class 2 device.
What It Is
The hemodialysis venous blood tubing set is a medical device used to transport blood during dialysis. It is designed to connect the patient to the dialysis machine, facilitating the removal of waste products from the blood.
FDA-Cleared Indications
- For use as a venous blood tubing set during hemodialysis procedures.
- For transporting blood between the dialyzer and the patient's vascular access during dialysis.
Clinical Applications
- Returning blood from the dialyzer to a patient during hemodialysis.
- Connecting the venous side of a dialysis extracorporeal circuit to a dialysis vascular access.
- Use during intermittent hemodialysis treatments in patients whose blood is being processed by a compatible dialysis machine and dialyzer.
Evidence Summary
The available literature includes 11 studies, with a mix of retrospective investigations and experimental models, spanning from 2002 to 2008. These studies explore various aspects of device safety and efficacy.
Reported Outcomes
Published studies report that the hemodialysis venous blood tubing set is effective in facilitating dialysis, but issues such as tubing kinks can lead to acute hemolysis. Other studies have examined the potential for electrical leakage and coagulation activation during use.
Safety Profile
Reported complications include acute hemolysis due to kinked tubing, which can result in significant decreases in circuit pressures and potentially fatal outcomes. Electrical leakage during dialysis has also been identified as a safety concern.
Evidence Limitations
The evidence is limited by the retrospective nature of some studies and the focus on specific complications. Further research is needed to explore long-term safety and efficacy across diverse patient populations.
Practical Considerations
- The tubing must be compatible with the dialysis machine, dialyzer, connectors, pressure-monitoring ports and other components of the extracorporeal circuit.
- Inspect the set before use for damage, contamination, loose connections, air, leaks or kinks. Kinking or obstruction can increase pressure and may contribute to blood damage, including hemolysis.
- The tubing is generally supplied sterile and intended for single use; follow the product labeling and facility policy for priming, connection, monitoring and disposal.
- The patient's access may be an arteriovenous fistula, arteriovenous graft or dialysis catheter. Correct connection and securement are essential to prevent blood loss or air entry.
- This is not an implanted device and does not have an independent MRI safety indication. MRI compatibility depends on the complete dialysis circuit and whether the set is connected to a patient or dialysis machine; consult the labeling and MRI safety policy.
Frequently Asked Questions
What are the clinical indications for hemodialysis venous blood tubing set?
The device is indicated for use in hemodialysis procedures to facilitate the transport of blood between the patient and the dialysis machine.
What outcomes have been reported in clinical studies?
Studies have reported effective blood transport during dialysis, but complications such as acute hemolysis due to tubing kinks have been noted.
What complications have been reported?
Safety data indicate complications such as acute hemolysis from kinked tubing and potential electrical leakage during dialysis.
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.