This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No debris were observed on device and on the tubing sets.Sample did not exhibited occlusion condition.The root cause of the reported issue cannot be determined, as the returned sample did not exhibited occlusion condition and no debris were observed on device and on the tubing sets.Awareness meeting with operators and quality inspectors to review the reported failure mode.Complaint data was reviewed on 08-mar-2022 and after reviewing the complaints history from march 2019 to date, it was found that this is the second complaint related to occluded/blockage defect.Previous complaint was not confirmed due to no product was returned for analysis.Additional information in h6 and h10.
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