Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981816
    Device Name
    CUE AMBULATORY VOLUMETRIC INFUSION PUMP
    Date Cleared
    1998-12-04

    (196 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BECTON DICKINSON CURLIN, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CareMEDS™ infusion pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions. Any therapy should be overseen by a physician or a certified, licensed healthcare practitioner. The infusion pump can provide therapy to patients/users who are ambulatory and needed an alternative to receiving their medication in a restricted manner (hospital or clinic). Typically, these patients are capable of being given instruction for performing basic tasks in operating the pump and maintaining medical care for themselves, or are assisted in these tasks by having a caregiver closely by, or living with them. All patients and caregivers must be instructed in the use of the CareMED5™ by a qualified clinician and demonstrate an adequate level of proficiency in the use of the pump. The CareMED5™ is small, lightweight and is designed to have exceptional ease of use so that after learning the pump features and basic of programming, the pump can be operated and can be customized to the specific needs of each individual patient without the need to constantly refer to the User's Manual.
    Device Description
    The "CareMEDS" Ambulatory Infusion Pump is a small, lightweight electro-mechanical pump utilizing a microcomputer and a Curvilinear (peristaltic type action) volumetric pumping mechanism that produces accurate fluid flow in the PVC tubing with very low wear effect on the tubing. The pump has 5 IV therapy modes and can be programmed for Continuous, TPN Automatic Ramping, Intermittent Delivery, Variable Program Delivery and Patient-Controlled Analgesia. The CareMEDS pump has a Curvilinear volumetric pumping mechanism that moves fluid through the PVC IV Set tubing by the action of 7 fingers sequentially pressing on the IV set tubing. The design of the mechanism produces an action that does not crush the IV tubing except for very localized pinch off area under the fingers, which results in very low wear on the tubing. The mechanism is driven through a worm gear by a DC motor with high efficiency. Ease of operating the pump is provided by a graphic LCD display which can present a large amount of operating information to the user and a numeric keypad with menu scroll keys, so that by following the "therapy specific" display prompts, operation of the pump is largely self evident. The pump is powered by either low cost "C" cell batteries, or external power sources. The pump has selfdiagnostics to check critical systems during start-up and for monitoring of performance while operating, as well as alarm sensors for detecting air, input and output occlusions in the IV set tubing, and the closure of the mechanism door. A history log records operating and alarm events and a communications data port provides remote operation and access to the history log for the downloading of recorded events. The pump has a rugged outer case and is water resistant with an easily operated door and keyed interfaces between the Administration IV Sets and the pump mechanism. Sterile administration sets made with all Class VI materials in the fluid path, are available with macrobore and microbore tubing and various sized filters and "Y" injection sites. All administration sets have automatic tubing clamps that work with the pump mechanism for anti-free flow protection when the IV Set is removed from the pump.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1