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There was a gas filter used in a fluid bearing line of the custom tubing pack. All computed tomography perfusion (CTPs) that were manufactured before the introduction of the new filter type and have not yet expired are affected. Preventive measure: a new…

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. Insufficient securement of…

Maquet Cardiopulmonary GmbH (MCp) became aware of various failure modes in regard to the Quadrox-I/-Id, vhk 11000 and vkmo 10000/ 11000 products in the course of six non-conformity reports. The identified failure modes can be divided into two categories…

Maquet Cardiopulmonary GmbH determined two trends for complaints regarding the Heater Cooler Unit HCU 40: degraded internal drain hoses and leaking vacuum valves. This recall will inform users, and give instructions to replace affected parts during next…

Potentially compromised sterile barrier.  The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed.  Single sterilized and transport conditioned according to ASTM d4169-22 was…

PLS set itself is delivered sterile and compliant, this issue relates to maintaining sterility after opening the pls set and removal of components (5) and (14) from the pls set tray for use in a later stage of extracorporeal circulation application.…

The former packaging design of HLS set contains accessories packed in medical paper as opposed to the new introduced packaging design in Tyvek. Based on design verification tests it showed that medical paper is a weaker technical solution than Tyvek,…

Statistical analysis indicates that with increasing operation time of the HU 35, the probability of leakage within its expected service life of 10 years increases due to material degradation of the tank fittings. Tank fittings and the screw cap of the…

Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the…

The tubing sets are designed and labeled for 2 years shelf-life from the manufacturing date. However, during a review of the technical documentation of tubing sets, it was found out that there is not sufficient evidence to demonstrate…