This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.One unopened sample was returned.The sample was not the sample that was reported as defected for occlusion.This was known due to the fact that the sample was returned in the sterile packaging unopened.Upon opening the sample the part was visually inspected under 10x magnification and found no signs of occlusion or intermittent occlusion in the part.Next, the sample was taken to the lab and water leak tested which includes priming each port of the sample.All testing came back positive with no occlusions or leaks.Next, the sample was tested per m.90 for plug/body hole alignment.This test requires that a 0.105 inch gauge pin be able to pass through all ports and plug holes with no greater than a 1/2 pound (lb) push.All holes were clear for the pin to pass through and required no pressure to enter.The root cause of the reported issue was found to be after review of the component, no signs of occlusion were found present.This sample was not the reported sample however so this does not mean that the sample(s) that were used as the customer facility did not experience this defect.If the defective components could be returned a more thorough investigation could be completed on the actual affected part.Based on the report, it is possible that the pump that is being used has a low backpressure alarm that could result from any interference in the line.Interferences could come in many forms.One such interference could be a diameter size change in the line due to the fluid traveling through the line having to change from one diameter size down to another smaller line, this would result in increased fluid velocity through the smaller line but may have a small back pressure effect from the wall section that is hit at the end of the larger diameter section.Recommendation was to check all lines and components for occlusion.
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