📊 Evidence-Based Reference
Braun Hemodialysis Catheter
Summary: The Braun Hemodialysis Catheter is a device used for vascular access in hemodialysis. It is primarily used in patients requiring long-term dialysis. Key evidence highlights its role in reducing unscheduled dressing changes and positioning challenges.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K952660 ↗
Decision Date ?
September 17, 1996
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Braun Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on September 17, 1996. It is manufactured by B. Braun Medical and classified as a Class 2 device.
What It Is
The Braun Hemodialysis Catheter is a central venous catheter designed for hemodialysis access. It facilitates efficient blood flow for dialysis treatment and is intended for patients requiring long-term vascular access.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Access through a central vein for removal and return of blood during dialysis treatment.
Clinical Applications
- Providing temporary or ongoing central venous access for hemodialysis.
- Connecting a patient to a hemodialysis circuit for blood withdrawal and return.
- Use in patients who require hemodialysis and do not have a usable arteriovenous fistula or graft.
Evidence Summary
The available literature includes 11 studies, with types ranging from randomized controlled trials to observational studies. The studies span from 2022 to 2025, focusing on catheter placement, infection prevention, and procedural efficiency.
Reported Outcomes
Published studies report that the use of procedural kits may reduce unscheduled central line dressing changes, potentially lowering infection risks. Accurate catheter tip placement is crucial for optimal function and patient safety.
Safety Profile
Reported complications include challenges in catheter tip placement, which can affect dialysis efficiency and patient outcomes. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence lacks detailed safety data and long-term outcomes. Further research is needed to establish standardized protocols for catheter placement and maintenance to minimize complications.
Practical Considerations
- The catheter is placed in a central vein, commonly the internal jugular, subclavian, or femoral vein, using sterile technique and often ultrasound and fluoroscopic guidance.
- Catheter size, length, lumen configuration, and tip position must be selected for the patient's anatomy and prescribed dialysis blood-flow rate.
- The catheter should be used and locked according to the manufacturer's instructions and the dialysis center's protocol; patency and dressing care require regular monitoring.
- Potential complications include infection, bleeding, thrombosis, air embolism, vessel injury, malposition, and inadequate dialysis flow.
- MRI safety depends on the specific catheter model and its materials. Confirm the exact product labeling before an MRI examination; do not assume that all Braun hemodialysis catheters have the same MRI status.
Frequently Asked Questions
What are the clinical indications for Braun Hemodialysis Catheter?
The catheter is indicated for use in patients requiring long-term vascular access for hemodialysis.
What outcomes have been reported in clinical studies?
Studies report reduced unscheduled dressing changes and emphasize the importance of accurate catheter tip placement.
What complications have been reported?
Safety data highlight challenges in catheter tip placement, though specific adverse events were not detailed.
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.