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transonic hemodialysis monitor cardiac output model hd01-co
Transonic Systems
Summary: The Transonic Hemodialysis Monitor Cardiac Output Model HD01-CO is used to measure cardiac output in hemodialysis patients. Key evidence highlights its role in assessing hemodynamic parameters and potential risks of high-output heart failure.
FDA Clearance Information
Pathway
510K
Number
K980906 ↗
Decision Date
October 6, 1998
Product Code
MQS
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 6, 1998, by Transonic Systems. It is classified as a Class 2 device under product code MQS.
What It Is
The Transonic Hemodialysis Monitor Cardiac Output Model HD01-CO is a medical device designed to measure cardiac output in patients undergoing hemodialysis. It utilizes ultrasound dilution technology to provide accurate hemodynamic assessments.
Clinical Applications
Commonly used in hemodialysis settings, this device helps clinicians monitor cardiac output and assess vascular access flow. It is particularly useful in evaluating the risk of high-output heart failure in patients with arteriovenous fistulas.
Evidence Summary
The literature includes 10 studies, comprising various study types such as prospective and retrospective analyses, with publication years ranging from 2010 to 2025. These studies focus on hemodynamic effects and validation of cardiac output measurement techniques.
Reported Outcomes
Published studies report that the device effectively measures cardiac output and vascular access flow, aiding in the assessment of hemodynamic stability. It has been validated against gold standard methods like ultrasound dilution, showing reliable performance in clinical settings.
Safety Profile
Reported complications include potential hemodynamic instability associated with high vascular access flow, which may increase the risk of high-output heart failure. No direct device-related adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the need for further research to explore long-term outcomes and broader patient populations. Some studies lack comprehensive safety data, indicating a need for more robust safety evaluations.
Frequently Asked Questions
What are the clinical indications for Transonic Hemodialysis Monitor Cardiac Output Model HD01-CO?
The device is indicated for measuring cardiac output and vascular access flow in hemodialysis patients, particularly those with arteriovenous fistulas.
What outcomes have been reported in clinical studies?
Studies have reported reliable cardiac output measurements and effective hemodynamic assessments, validated against gold standard methods.
What complications have been reported?
Reported complications include hemodynamic instability due to high vascular access flow, potentially leading to high-output heart failure.
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.