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emergency infusion device
Arrow Intl.
Summary: The emergency infusion device by Arrow Intl. is designed for rapid fluid administration in critical care settings. It is FDA 510k cleared and supported by 15 studies, highlighting its use in prehospital and emergency environments.
FDA Clearance Information
Pathway
510K
Number
K840455 ↗
Decision Date
May 23, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The emergency infusion device was cleared by the FDA through the 510k pathway on May 23, 1984. It is manufactured by Arrow Intl. and classified as a Class 2 device.
What It Is
The emergency infusion device is a medical tool used to administer fluids rapidly in emergency situations. It is particularly useful in scenarios requiring quick resuscitation, such as hypovolemic shock or severe blood loss.
Clinical Applications
Commonly used in prehospital and emergency department settings, this device facilitates rapid infusion of fluids and blood products. It is crucial in managing patients with severe trauma or cardiac arrest.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from 2011 to 2024, providing a comprehensive overview of the device's clinical application.
Reported Outcomes
Published studies report that the emergency infusion device effectively facilitates rapid fluid administration, which is critical in life-saving interventions. The device is noted for its utility in prehospital settings, allowing for high-volume infusion of blood products.
Safety Profile
Reported complications include rare adverse events associated with intraosseous infusion, as noted in emergency scenarios. The device's use in critical settings underscores the importance of proper training to minimize risks.
Evidence Limitations
While the device is supported by multiple studies, there is a need for more large-scale, randomized trials to further validate its efficacy and safety. Current evidence is limited by the variability in study designs and patient populations.
Frequently Asked Questions
What are the clinical indications for the emergency infusion device?
The device is indicated for rapid fluid and blood product administration in emergency and prehospital settings, particularly for patients in shock or with severe trauma.
What outcomes have been reported in clinical studies?
Studies report effective rapid fluid administration, crucial for resuscitation in emergency scenarios, with noted utility in prehospital environments.
What complications have been reported?
Safety data indicate rare adverse events with intraosseous infusion, emphasizing the need for proper training in emergency use.
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.