Heat Exchanger for heart-lung bypass

The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004, as the only responsible source that can provide two heat exchangers for heart-lung bypass surgeries for NNMC Bethesda. The requirement is for two heat exchangers for heart-lung bypass surgeries. The accessories included with this system shall be the following: overflow bottle, tubing container (1/2- straight), tubing connector (1/2 - 90), and grounding wire. These heat exchangers shall have three water baths to heat/cool the blood/cardioplegia/water blanket independently. The system shall have a patient circuit flow rate of 15-17 LPM and a cardioplegia circuit flow rate of 9 - 11 LPM. The system shall have a patient circuit tank volume of 4.5 - 6.5 liters and a cardioplegia circuit tank volume of 3 liters. The heart-lung bypass heat exchangers shall be used to lower the temperature of the blood, reducing the metabolic requirements of the heart and the oxygen demand of the brain and other organs during surgery and to re-warm the blood at the end of the surgical procedure. The heat exchanger system is to be using with NNMC Bethesda's existing Terumo Heart-Lung Bypass Systems. The voltage requirements of the heat exchanger are 110 VAC, 60 Hz, 16 Amps, and single phase. Regulatory Requirements: The system and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to erin.cotter@med.navy.mil. No phone calls accepted.