SOLICITATION NOTICE
66 -- Extracorporeal Perfusion Pump
- Notice Date
- 7/17/2015
- Notice Type
- Presolicitation
- NAICS
- 339113
— Surgical Appliance and Supplies 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
- N6264515RCES017
- Point of Contact
- Andrew A. Hampton, Phone: 3016193115
- E-Mail Address
-
andrew.a.hampton3.civ@mail.mil
(andrew.a.hampton3.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND NOTICE OF INTENT The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.106-1(b)(1)) with Maquet Cardiovascular US Sales LLC, 45 Barbour Pond Dr., Wayne, NJ, 07470-2094, 804 310-3141, as the only responsible source that can provide an Extracorporeal Perfusion Pump. This Extracorporeal Perfusion Pump is for Naval Medical Center Portsmouth, Portsmouth, VA. The requirement is for an Extracorporeal Perfusion Pump. The system shall be capable of performing extracorporeal gas exchange and reinfusion of blood, generally during cardiopulmonary bypass procedure for up to 6 hours. The system shall help protect against insufficient supply of oxygen to vital organs. The system shall provide circulatory and pulmonary support during procedures not requiring cardiopulmonary bypass for up to 6 hours. The system shall be capable of operating in critical care, cardiac catheterization laboratories, and operating rooms. The system shall be capable of providing at least 90 minutes, while on battery power, of circulatory and pulmonary support to a patient while in transport to and from a hospital. The extracorporeal perfusion pump shall be portable to transport with a patient out of the hospital to a transplant center. The system shall include a cart with a height adjustable shelf, infusion pole, and a retractable shelf for storage of accessories. The system shall include an emergency drive mechanism to manually drive the disposable set in case of system failure during a procedure. The extracorporeal perfusion pump shall have an auto-priming feature that allows the system to be used by Cardiac Surgeons at the bedside in the Intensive Care Unit, without the immediate availability of a Perfusionist. The device shall also include an oxygen tank holder. The extracorporeal perfusion pump shall include disposable sets that integrate gas exchange, heat exchange with a centrifugal pump. The systems disposable set shall have 3 integrated pressure sensors for venous, arterial, and internal pressure. The systems disposable sets that come in contact with blood shall be composed of biocompatible material. The extracorporeal perfusion pump disposable sets shall be used in duration for up to 6 hours. The system shall have the ability to operate on single phase at 110Vac, 60 Hz, and on less than 30A. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system 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 Maquet Cardiovascular US Sales LLC This acquisition is being conducted under FAR Part 12 and 13. Provisions and clauses in effect through Federal Acquisition Circular 2005-83 are incorporated. This acquisition is being conducted under simplified acquisition procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339113 with a Small Business Size Standard of 500 employees. 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. Capability statements (formats for submission: PDF, MS Word, or MS Excel) should be sent to Andrew Hampton at andrew.a.hampton3.civ@mail.mil. Closing date for capability statements is no later than 3:00 PM EST on 03 Aug 2015. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264515RCES017/listing.html)
- Record
- SN03802061-W 20150719/150717235750-3de2962c4b2e87ba8a4bdf90dea8448b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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