The details of this complaint "identified bubbling and presence of blood in the vacuum chamber in the reservoir of the oasis atrium drainage system in the postoperative period of the rsbb patient on (b)(6) 2022, requiring the replacement of the entire set.No injuries to the patient." this was identified during the treatment of the patient.The video provided of the drain in use confirms the reported event, however, the drain appears to be working as expected.Upon review of the video, it would appear as if the chest drain was knocked over at some point during use or was allowed to over flow.Within the attached video the stand of the drain is not properly set to stabilize the drain.It is not in the locked position.Other evidence is that there is blood on the float ball at the top of the drain showing that blood had come in from the top of the drain in column "b" as seen in the attached image.If the drain were knocked over this is where the blood would enter down into the water seal/air leak monitor area "c".If the drain were to overflow this is also the path the blood would take as well.A review of dhr 471064 was performed and all devices in lot: 471064 passed all quality requirements.No non-conformities were identified in the manufacturing process.The investigation has determined that the most likely root cause of the reported event is that the drain was knocked over during use ¿ operational context h3 other text: not available for return.
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