Description from the customer report: "after 3 days of treatment, perfusion noticed that the venous pressure was reading +5mmhg.They used external pressure transducer to compare the internal and arterial readings and found a 20 mmhg discrepancy.They have no way of confirming the venous pressure since there are no luers on the venous side of the hls circuit but assume that since the venous pressure is reading positive values, it mist also be erroneous.They are monitoring the system closely.The circuit was discontinued as they weaned the patient." (b)(4).
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An hls advanced 7.0 module was returned to the factory in (b)(4) for investigation.During flushing of the oxygenator, no clots were visible.After cleaning, a crack on the luer lock of the blood outlet connector was found.The responsible quality engineer was informed, and the crack was glued to seal it, and the module was sent to the qa-laboratory for performance testing.The results of the performance testing from the qa-laboratory showed that while the gas exchange performance tests were passed by the product, it failed the pressure drop performance test.The product was returned to the decontamination / complaints laboratory where all four sides of the oxygenator were sawn open and the mats were inspected for damage, marks, or other anomalies.On the gas side, small clots could be seen between the mats.On the water side, larger/more clots could be seen between the gas and the water mats.No clots were visible on the blood distribution plate on the blood outlet side.The count of the gas mats (74) was within specification (a count 72, 74, or 76 is specified).The investigation concluded the most probable root cause for the increased pressure drop was blockage of the oxygenator as a result of clotting.As clotting can result from a number of causes, including patient condition, the anticoagulation measures in use, and other clinical factors, the exact reason for the clotting cannot be identified.A systemic issue is not indicated.No further investigation or action is currently warranted.
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