đź“Š Evidence-Based Reference
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray
Summary: The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray is designed for hemodialysis access in patients with renal failure. Key evidence highlights its use in managing ESRD patients, with studies focusing on dialysis outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K161504 ↗
Decision Date ?
January 6, 2017
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray was cleared via the FDA 510(k) pathway on January 6, 2017. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray is a medical device used to establish vascular access for hemodialysis in patients with renal failure. It facilitates efficient blood flow during dialysis sessions.
FDA-Cleared Indications
- Hemodialysis vascular access in patients with renal failure.
- Temporary, non-implanted central venous access for acute hemodialysis.
- Use when vascular access is needed to withdraw blood for dialysis and return it to the patient.
Clinical Applications
- Placement of temporary central venous access for acute hemodialysis.
- Hemodialysis in hospitalized patients with acute kidney injury or renal failure.
- Dialysis access for patients who do not yet have a functioning permanent arteriovenous fistula or graft.
- Short-term dialysis access while a more durable access strategy is planned or becomes usable.
Evidence Summary
The available literature includes 9 studies, primarily retrospective analyses and case reports, conducted between 2016 and 2024. These studies explore dialysis outcomes and complications in ESRD patients.
Reported Outcomes
Published studies report that the Cook Turbo-Flo HD catheter is effective in providing vascular access for hemodialysis in ESRD patients. However, specific outcomes related to the device itself are not detailed in the provided evidence.
Safety Profile
Reported complications include renal dysfunction and hepatic dysfunction, as noted in a case report involving methotrexate use. However, direct complications related to the catheter are not specified in the available studies.
Evidence Limitations
The evidence lacks specific studies directly evaluating the Cook Turbo-Flo HD catheter's performance and safety. Further research is needed to assess long-term outcomes and device-specific complications.
Practical Considerations
- The catheter is non-implanted and intended for temporary use; the exact duration depends on the clinical situation, institutional policy, and product labeling.
- Placement is generally performed through a central vein, commonly the internal jugular or femoral vein, using sterile technique and imaging guidance when appropriate.
- Catheter size, length, lumen configuration, and included tray components should be selected according to the patient’s anatomy, dialysis requirements, and the specific product instructions for use.
- Potential complications include bleeding, infection, thrombosis, vessel injury, malposition, air embolism, and inadequate blood flow.
- MRI conditions and compatibility must be confirmed in the current Cook product labeling; do not assume the catheter or all tray components are MRI safe.
Frequently Asked Questions
What are the clinical indications for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set Tray?
The device is indicated for establishing vascular access for hemodialysis in patients with renal failure, particularly those with ESRD.
What outcomes have been reported in clinical studies?
Studies focus on dialysis outcomes in ESRD patients, but specific outcomes related to the catheter are not detailed.
What complications have been reported?
Reported complications include renal and hepatic dysfunction related to methotrexate use, but not directly linked to the catheter.
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.