6515--Vitaflow Capital Bundle w/ Cart Brand Name or Equal

Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 01/15/2026 Revision: 03 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format Revolutionary FAR Overhaul (RFO) in Federal Acquisition Regulation (FAR) subpart 12.202, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01. This solicitation is set aside for Small-Business The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,000 Employees The FSC/PSC is 6515. The West Haven VA Medical Center 950 Campbell Avenue West Haven VA, CT 06516 2770 is seeking to purchase the following items from below. The West Haven VA Medical Center is seeking (1) Vitaflow Capital Bundle w/ Cart Brand Name Medtronic or Equal. This is a new brand name or equal requirement. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure VITALFLOW CAPITAL BUNDLE WITH CART INCLUDES: 1 EA 58100 VITAL FLOW CONSOLE(INCLUDES FLOW & BUBBLE SENSOR, POWER CORD) 1 EA 58102 58102 MOTOR DRIVE & HOLDER; 1 EA 58103 58103-EMERGENCY HANDCRANK; 1 EA 58130 58130-OXYGENATOR DATA CABLE 1 EA 58120 58120-VITALFLOW TRAVEL CADDY 1 EA ECM-9688-1 VITALFLOW CART 1 EA DELIVERY LOCATION: West Haven VA Medical Center Jamaica Plain VA Medical Center 950 Campbell Avenue West Haven VA, CT 06516 2770 FOB: Destination Statement of Work West Haven VA Medical Center ECMO System Statement of Work 1. General Information The Extracorporeal Membrane Oxygenation (ECMO) system requested under this Statement of Work is an advanced life support platform that temporarily takes over the function of a patient's heart and lungs. It is designed to provide cardiopulmonary support for critically ill adults facing acute, life-threatening respiratory or cardiac failure. This is a brand name or equal requirement. The Medtronic VitalFlow ECMO system is cited as representative of the salient characteristics required (see Section 5, Equipment Specifications/Salient Characteristics). Any product offered as an equal must meet or exceed all salient characteristics listed. This is not a sole-source or brand-name-only requirement. 2. Background The Surgical Department at the West Haven VA Medical Center (VA Connecticut Healthcare System) has identified a need for an ECMO system to support cardiopulmonary care for critically ill Veterans. Any offered system, including VitalFlow or an equal, will be evaluated against the salient characteristics in Section 5. 3. General Requirements The Vendor shall be capable of delivering the entire required quantity of units to all designated sites within the required time frames. Vendor shall ensure compliance with all applicable laws concerning construction, packaging, labeling, registration, and transportation of the equipment. The Vendor shall not make unannounced alterations to the design or components of delivered equipment without prior notification and written approval by the Contracting Officer's Representative (COR). The Vendor shall deliver all units within 60 days of contract award. 4. Regulatory and Compliance Requirements The offered system, whether VitalFlow or an equal, shall hold current FDA clearance/approval (e.g., 510(k) or PMA, as applicable) for its intended use in adult cardiopulmonary life support. The offered system shall comply with applicable VA medical device cybersecurity requirements, including VA Handbook 6500 and Medical Device Isolation Architecture (MDIA) requirements, where applicable. 5. Equipment Specifications / Salient Characteristics To be considered an acceptable "equal" product, an offered ECMO system must meet or exceed the following salient characteristics. Characteristic Required Specification FDA clearance / regulatory classification Class II device cleared under 21 CFR 870.4100 (Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure), or equivalent product code classification (e.g., QNR for pump/console, BYS for oxygenator) Indicated duration of use Indicated for continuous ECMO support up to 48 hours Indicated patient population Adult patients with acute respiratory failure or acute cardiopulmonary failure, where other treatment options have failed System configuration Complete system including console, centrifugal blood pump, membrane oxygenator, backup/emergency manual drive mechanism, and mobile transport cart Console weight 9 kg (console unit only, excluding cart/accessories) Intra-hospital transport certification Certified for intra-hospital patient transport per ISO 60601-1 (or equivalent recognized standard) Emergency backup drive Manual emergency hand-crank or equivalent non-electric backup drive mechanism, independent of external power External/DC motor drive option DC-powered external drive motor compatible with the pump, for use during transport or power loss Blood-contacting material composition DEHP-free blood-contacting surfaces on the disposable circuit/set Oxygenator/pump disposable set Complete single-patient disposable set including oxygenator, tubing, and priming/prime bag, compatible with the offered pump and console Mobility/cart configuration Configurable mobile cart or stand permitting bedside and transport use, with accessory mounting (oxygenator holder, pole mounts, etc.) Training/education support from vendor Vendor-provided clinical education and hands-on training (see Section 6) 6. Education and Training The Vendor shall provide comprehensive education and hands-on training on the offered ECMO system for VA hospital clinical staff, ensuring safe and effective use in patient care. All relevant clinical staff shall be trained, including perfusionists, physicians, nurses, respiratory therapists, and biomedical engineers who will work with the device. Training format on-site, virtual, or hybrid] Number of training sessions and duration] Competency validation/sign-off requirements] Provisions for ongoing/refresher training and training for new hires post-award] 7. Records Management Language for Statement of Work (SOW) The following standard items relate to records generated in executing the contract and shall be included in the procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government, for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractors must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those associated with safeguarding records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format (paper, electronic, etc.), mode of transmission (e-mail, fax, etc.), or state of completion (draft, final, etc.). No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may…