Search Results
Found 1 results
510(k) Data Aggregation
K Number
K063696Device Name
COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
Manufacturer
Date Cleared
2007-02-27
(76 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
BAXTERHEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The COLLEAGUE Volumetric Infusion Pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components.
The COLLEAGUE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes.
The COLLEAGUE pump is intended for use in a wide variety of patient care environments for adult, pediatric and neonatal patients. The COLLEAGUE pump facilitates the delivery of routine and critical infusion therapies via continuous and intermittent delivery using primary and piggyback infusion modes.
The COLLEAGUE pump can be used in the following care areas:
- General Floor of the Hospital
- Critical / Intensive Care
- Neonatal Intensive Care
- Pediatric Care
- Labor / Delivery / Postpartum
- Operating Room / Anesthesia
- Post Anesthesia / Recovery
- Cardiac Catheterization Lab
- Emergency Room
- Ground Ambulance
- Hospice Facility
- Outpatient / Subacute Facilities
- Nursing Facilities
- Long Term Care / Rehabilitation Facilities
- Diagnostic Nuclear Medicine
- Oncology Floor
- Burn Unit / Trauma
Device Description
The COLLEAGUE Volumetric Infusion Pump product is a software controlled, electromechanical, large volumetric infusion pump that includes either one or three infusion channels. The COLLEAGUE Volumetric Infusion Pump product provides the necessary infusion therapy modes to deliver medications and solutions through a Baxter standard administration set. The pump uses a shuttle pumping mechanism to achieve flow. None of the pump device materials come in contact with the solution path.
The COLLEAGUE Volumetric Infusion Pump is designed to accept Baxter standard administration sets equipped with keyed slide clamps that are labeled as being COLLEAGUE pump compatible. The unidirectional slide clamp helps ensure proper set loading. The pump will accept a variety of currently marketed solution containers including flexible containers, glass bottles, and syringes (with an accessory adapter).
The pump is intended to operate primarily on AC power and is equipped with a rechargeable battery to facilitate use during transport.
The COLLEAGUE GUARDIAN feature is a configurable option that helps to reduce the potential for medication programming errors by allowing program limits to be predefined for labels in the pump's label library, including custom labels, based on hospital or care area protocols.
The COLLEAGUE GUARDIAN feature (Monochrome and CX devices) is available for dose mode programming only. The COLLEAGUE GUARDIAN feature allows the facility to set up labels for programming standard concentrations of a dose mode infusion.
The COLLEAGUE Enhanced GUARDIAN feature (CXE devices) is a configurable option that is available for both rate/volume and dose mode programming. The COLLEAGUE Enhanced GUARDIAN feature allows the facility to set up labels set up for programming nonstandard concentrations of a dose mode infusion (modifying the Drug Amount, Diluent Volume and/or Concentration from the default.
The COLLEAGUE Volumetric Infusion Pump supports the use of a proprietary software accessory; COLLEAGUE GUARDIAN Configuration Tool. The configuration tool supports the creation and maintenance of Personalities (custom feature set for individual care area or for specific therapies), as well as the clinical labels and parameters established by the hospital using the COLLEAGUE GUARDIAN dose error reduction software. This software accessory is not required to operate the pump.
The COLLEAGUE Volumetric Infusion Pump also supports the use of proprietary software accessory: COLLEAGUE DL2 Event History Download Software Application. The COLLEAGUE DL2 Event History Download Software Application is a service application that downloads the event history log. This software accessory is not required to operate the pump.
The COLLEAGUE Volumetric Infusion Pump has the ability to communicate externally via a data communications interface.
Ask a Question
Ask a specific question about this device
Page 1 of 1