The drain was received and inspected.The drain was found to have a large amount of bodily fluid still within the drain including in the waterseal portion of the drain.The drain was cleaned and disinfected.A mixture of water and blue die was placed in the drain filling all of the chambers.The result was that no die was leaking into the water seal portion of the drain.The drain was then placed under vacuum to simulate normal use conditions.During the test none of the blue water transferred into the waterseal portion of the drain.All drains are 100% leak tested during the manufacturing process and this lot of drains was found to have met all specifications.Based on the complaint investigation results, the drain is functioning properly and there are no leaks or cracks within the drain.It is not known how bodily fluid collected in the waterseal portion of the drain; however, if a drain is knocked over or allowed to overflow fluid could get into the waterseal portion of the drain.Clinical evaluation: the oasis chest drainage system is indications for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates post-operative collection and reinfusion of autologous blood from the patient¿s pleural cavity or mediastinal area.The instructions for use (ifu) advise to always place chest drain below the patient¿s chest in an upright position.To avoid accidental knock over, open the floor stand for secure placement on the floor or hang the system bedside with the hangers provided.The ifu also states to replace chest drain if damaged or when collection volume meets or exceeds maximum capacity.Related mdr 3011175548-2018-00557.
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