SOLICITATION NOTICE
65 -- HEART LUNG BY-PASS UNIT
- Notice Date
- 5/15/2014
- Notice Type
- Presolicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264514RCES037
- Archive Date
- 7/11/2014
- Point of Contact
- Brian D. Miller, Phone: 3016191086
- E-Mail Address
-
brian.miller4@med.navy.mil
(brian.miller4@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is Sorin Group USA, Inc. of 14401 W 65th Way, Arvada, CO 80004. Naval Medical Center Portsmouth has a requirement for two (2) heart-lung bypass units [11-969]. 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 consistent with the equipment utilized by Sentara Cardiovascular Support Team to ensure the safety of the patients during cardiac procedures. The systems shall be modular in design, and individual components and modules shall be able to be added and removed from the system. The systems 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 systems shall have three (3) single roller pumps that are operable in continuous or pulse mode. The systems shall include one (1) centrifugal pump. The systems shall have a locking wheel/knob mechanism for inclusion adjustment to prevent accidental adjustment. The systems shall have an arterial line clamp. The systems shall have at least two pressure sensors and at least four temperature sensors. The systems shall be capable of monitoring venous saturation, hematocrit, and venous temperature. The systems shall be able to stop the connected pump when an air bubble is detected within the tubing. The systems shall have a cardioplegia sensor capable of automatic and manual operational modes. The cardioplegia sensor shall also be capable of measuring the total volume delivered from the start of the procedure. The systems shall have a level sensor capable of detecting when blood falls below acceptable levels in the unit. The systems shall have both audible and visual alarms. The systems shall have an electronic gas blender with four connectors for Air, O2, CO2, and total gas flow. The systems shall have at least three timers which can be set independently. The units shall have an attached LED lamp. The systems 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 units is 120VAC, 60Hz. The systems shall also include a warming/cooling unit, patient, heart-lung bypass [17-206]. The warming/cooling units shall have separate cold and warm water tanks to allow for fast changes between warm and cold cardioplegia. The warming/cooling units shall have separate water circuits 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 systems 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. Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Brian Miller at brian.miller4@med.navy.mil. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller, reference solicitation number N6264514RCES037. Email challenges are preferred. Closing date for challenges is no later than 2:00pm. ET on 30 May 2014. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264514RCES037/listing.html)
- Place of Performance
- Address: Naval Medical Center Portsmouth, Portsmouth, Virginia, United States
- Record
- SN03367452-W 20140517/140515235100-e357edce14fc9319124f7a237c9e9611 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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