P08025: LVAD Durability Test Machine
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Mission Statement

Table of Contents

Product Description

Carna is an all inclusive automated fixture for the testing and monitoring of the LVAD-R2 [Magnetically Levitated Axial Flow Heart Pump]. It will consist of ten mock human circulatory loops that the LVAD-R2's will interface with. The loops will emulate flow and pressure characteristics of a human waking/sleeping/active both for a healthy human and one with congestive heart failure. It will provide real-time monitoring of multiple blood pumps simultaneously for a period of at least two years un-interrupted. This system will exist and maintain its own environment, to prevent from any outside interference. All data will be stored off-line and will be available via network for observation and analysis.

Key Business Goals

This product is a critical tool to help provide FDA approval of the LVAD-R2 for initial clinical trials with human users. More specifically this will provide an Investigational Device Exemption [IDE] which allows LVAD-R2 to reach the clinical testing phase.

Primary Market

Medical Device Design (Blood Pumps specifically).

Secondary Market

Any company requiring automated durability testing for their products, such as commercial and industrial pumps used in mission critical applications. This can be extended to any mission critical device.

Assumptions and Constraints

  1. It is assumed that a saline solution is used instead of human blood.
  2. It is assumed that all ten LVAD devices are identical.
  3. It is assumed the durability testing machine will be housed in a temperature controlled environment.
  4. Constraints are described in FDA CFR Parts 21 and 812.
  5. System must be automated, and self-diagnosing.
|21 CFR Part 56: Institutional Review Board
|21 CFR Part 812: Investigational Device Exemption

Stakeholders

Dr. Steven Day
Project Manager/Lead In-House Consultant for the LVAD-R2
Dr. Don Olsen
President of the Utah Artifical Heart Institute (Primary Funding for LVAD-R2 project),

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