SPECIAL NOTICE
65 -- two (2) ea. heart-lung bypass units [11-969] with associated modules and components. - Justification and Approval
- Notice Date
- 7/14/2015
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264515
- Archive Date
- 8/14/2015
- Point of Contact
- Deborah L. Hagan, Phone: 3016199357
- E-Mail Address
-
Deborah.Hagan@med.navy.mil
(Deborah.Hagan@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- Justification and Approval The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis with the Sorin Group USA, Inc., 14401W. 65th Way, Arvada, CO 80004-3599, as the only responsible source that can provide two (2) ea. heart-lung bypass units [11-969] with associated modules and components. The systems shall be able to provide temporary external circulatory support for open heart surgery. The systems shall be able to oxygenate venous blood and pump it throughout the arterial system. The systems shall be consistent with the equipment utilized by currently trained contractor personnel (Apex Perfusion, Inc.) to ensure the safety of the patients during cardiac procedures. There are no other manufacturers that can provide heart-lung bypass units consistent with the equipment utilized by currently trained contractor personnel (Apex Perfusion, Inc.). Apex Perfusion, Inc. provides a Certified Clinical Perfusionist (CCP) for cardiac surgeries. The system shall be modular in design, and individual components and modules shall be able to be added and removed from the system. The system shall have a mast system for the positioning of different accessories. The systems shall have an emergency uninterruptible power supply equipped with a manual crank. The uninterruptible power supply shall be capable of up to 90 minutes of bypass operating time depending on the workload. The system shall have two (2) ea. single roller pumps and two (2) ea. double roller pumps that are operable in continuous or pulse mode. At least one of the single roller pumps shall be mast mountable. The system shall include one (1) ea. centrifugal pump. The system shall have a locking wheel/knob mechanism for inclusion adjustment to prevent accidental adjustment. The system shall have an arterial line clamp. The system shall have at least two pressure sensors and at least four temperature sensors. The system shall be capable of monitoring venous saturation, hematocrit, and venous temperature. The system shall be able to stop the connected pump when an air bubble is detected within the tubing. The system shall have a level sensor capable of detecting when blood falls below acceptable levels in the unit. The system shall have both audible and visual alarms. The system shall have an electronic gas blender with four connectors for Air, O2, CO2, and total gas flow. The system shall have at least three timers which can be set independently. The unit shall have an attached LED lamp. The system shall have cable holding and organizing systems and clamps to allow for proper positioning of the system during procedures. The power requirement for the heart-lung bypass unit is 120VAC, 60Hz. The system shall also include a warming/cooling unit, patient, heart-lung bypass [17-206]. The warming/cooling unit shall have separate cold and warm water tanks to allow for fast changes between warm and cold cardioplegia. The warming/cooling unit shall have a separate water circuit for controlling the temperature of the patient and for controlling the temperature of the cardioplegia solution. The power requirement for the warming/cooling units is 120VAC, 60Hz. Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The system 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. The system shall be installed in compliance with OSHA requirements. Based on the above information, the only technically acceptable system is provided by The Sorin Group USA, Inc. There are no set-aside restrictions for this requirement. 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 shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification 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 normally be considered solely for the purpose of determining whether to conduct a competitive procurement. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Deborah Hagan at deborah.l.hagan.civ@mail.mil. Closing date for challenges is no later than 2:00 PM ET on 30 July 2015. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264515/listing.html)
- Place of Performance
- Address: San Diego CA, San Diego, California, United States
- Record
- SN03796616-W 20150716/150714235803-dcd6c58a061a403b8b98dbcefe7fc77a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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