Identification of the medical device
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ADVERSE EVENTS, LIVER
ECD liver grafts will be perfused with hypothermic oxygenated perfusion (HOPE) via the portal vein only for a minimum of 1 h (ideally 1–4 h) after the “back-table” phase (graft preparation). This will be performed, in parallel with the recipient hepatectomy, using the CE-certified Liver Assist® perfusion pump/device (XVivo®, Sweden) with Machine Perfusion Solution (Belzer-MPS, CE-certified). Ideally, the graft should be placed in the machine before or at the time of the incision of the recipient to allow a duration of machine perfusion of the graft between 1 and 4 h. The machine perfusion time should not exceed 4 h. However, if the hepatectomy phase is longer than expected, the graft can remain on perfusion and used for transplantation. A notification of adverse events with specific interest will have to be done if the hypothermic oxygenated perfusion lasted more than 4 h.The Liver Assist® is a pump system providing temperature-controlled dual oxygenated isolated perfusion of donor livers to bridge the time span between the donor hepatectomy and the liver transplantation in the recipient.The Liver Assist® is a modular system consisting of five main modules:Portal vein pump unit (for portal vein perfusion)Hepatic artery pump unit (for hepatic artery perfusion) ( Thermo unitTrolley including table topDisposable setThe device incorporates neither medical substances nor non-viable materials of animal origin.Date of CE mark: CE 663647 25/11/2016.Market authorization: November 29, 2006.