6515--Intent to Sole Source VitalFlow System **EMERGENCY**

The Department of Veterans Affairs, WNY Healthcare System, intends to award a sole source contract to Medtronic USA, Inc. for the procurement of a VitalFlow Capital Heart-Lung Bypass unit. This unit is necessary to replace the current Cardiohelp Heart-Lung Bypass unit, which has been recalled by the FDA due to multiple issues. The new unit will ensure device uptime in the OR and provide the best care possible for veterans. The procurement is considered an emergency due to the limited treatment available to patients without a functioning Heart-Lung Bypass unit. • The current Cardiohelp Heart-Lung Bypass unit is on an FDA recall and cannot be used. • The vendor, Getinge, has failed to remediate the issues, leading to the FDA's recommendation for replacement. • The Buffalo VA Medical Center has been operating without a Heart-Lung Bypass unit, limiting the treatment available to patients. • The procurement of the VitalFlow Capital Heart-Lung Bypass unit is estimated to cost $92,795.00.