Analysis: the oasis chest drains in question were evaluated to determine the cause of the complaint.Upon review of the returned tube sets there was one kink in the same location on every tubing set evaluated.To determine if the kink in the tubing prohibited flow each tubing set was tested per test procedure.The test procedure was created and derived based on the requirements set forth in iso standard bs en iso 10079-3 2014.The results of this testing indicate that even with the kink in the tubing the airflow met the procedural requirements of 7.5 slpm.The lowest value seen was 27.5 slpm.This far exceeds the procedural requirement.To date there have been no other complaints from around the world.Except from the two institutions in australia.There have been over (b)(4) units produced since this change was implemented in february of 2019 summary/conclusion: based on the results of the investigation atrium medical corporation cannot conclude that the patient tube set kinking creates a patient risk.
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