Norway – Medical equipments, pharmaceuticals and personal care products – 77394 OUS KLM IMM Plasmapheresis Machine – Notice of Intent to Award

Justification for Direct Award The Blood Bank is expanding its operations into new facilities and requires four new plasmapheresis instruments that must operate seamlessly with the existing ISO‑certified solution based on Fresenius Kabi equipment integrated via DXT and ProSang. To the best of our knowledge, no other plasmapheresis instruments on the market today are technically compatible with the established middleware or capable of integrating directly with ProSang without development of a new integration solution. Operation of parallel systems is considered unacceptable due to increased risk, complexity, training needs, and significant additional operational and quality‑related costs. Full replacement of the current equipment is also not feasible, as the existing machines have substantial remaining service life and represent major investments. See the attached document for a detailed justification. Based on this, it is assessed that only Fresenius Kabi Norway AS can supply plasmapheresis equipment that meets the Blood Bank’s technical requirements. Four (4) Aurora plasmapheresis instruments from Fresenius Kabi AS will therefore be procured. The conditions for a direct award without competition under FOA § 13‑4 (2) are considered fulfilled. Competition is impossible for technical reasons. Any objections must be submitted to the project manager within 10 days after publication of the notice.