(b)(4).The hls module advanced 7.0 was returned to the factory and investigated in the decontamination / complaints laboratory.No blood clots were visible on flushing out the oxygenator.The dialysis connector was found to be clotted.For further examination, the product was forwarded to the qa laboratory.In the qa laboratory, the product was tested for its gas exchange performance for o2 and co2, and also a pressure drop test was performed.The product passed the gas exchange performance tests, but failed the pressure drop test, confirming the customer's reported issue.The product was then sent back to the decontamination / complaints laboratory, where all four sides of the oxygenator were sawn open, and the mats were inspected for any signs of damage, marks or any other anomalies.No anomalies were found.The number of gas mats was also counted, and there are 74 (a count of 72, 74, or 76 is specified).There were no signs of any clotting between the mats, or anything else of note.In conclusion, the results of the pressure drop test supports the customer's reported issue, however internal examination of the oxygenator found no anomalies, so a clear root cause could not be established.Based on the investigation and trending for this issue, a systemic issue is not indicated (this is an isolated case), therefore no further investigation or action is currently warranted in addition to continued periodic monitoring, and the complaint will be closed.
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