Intent to Sole Source VitalFlow System **EMERGENCY**

Special Notice Special Notice Page 3 of 3 Page 1 of Special Notice *= Required Field Special Notice Page 1 of 3 Page 1 of 1 This is a notice of intent to award a sole source contract and is not a request for quotes. The Department of Veterans Affairs WNY Healthcare System intends to award a Firm Fixed Price Sole-Source action to:

Name of Contractor:

Medtronic USA, Inc Street Address:

710 Medtronic Parkway NE City, State, Zip: Minneapolis, MN 55432 The Buffalo VA Medical Center is working to replace the current Cardiohelp Heart-Lung Bypass unit. The FDA has issued a notice recommending the replacement of these units. There have been multiple recalls on these devices that the vendor has failed to remediate which has led to this decision by the FDA. Currently, our OR has no Heart- Lung Bypass unit to use.

Therefore, the Buffalo VAMC is seeking to purchase one (1) Vitalflow Capital Heart Lung Bypass unit to conform with FDA replacement recommendation. Procuring this equipment will ensure device uptime in our OR so that Veterans are receiving the best care possible. Because of the multiple recalls issued on our current CardioHelp Heart-Lung Bypass unit, the OR has been operating without a Heart-Lung bypass unit.

It is crucial that we get this procured as soon as possible due to the limited treatment that can be provided to veterans. So, it is imperative that we sole source to Medtronic, Inc for the reason of getting the OR a functioning Heart-Lung Bypass unit. This is a Emergency Procurement IAW FAR 6.302-2 Use of other than full and open competition for unsual and compelling urgency . This notice of intent to award a sole source contract is not a request for competitive proposals.

There will be no solicitation available for competitive quotes. The Veterans Health Administration prohibits the use of gray market items in their Medical Centers. Gray market items are considered to be items outside of the original equipment manufacturer s intended distribution channels.