This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was provided for evaluation.The sample was visually evaluated and functionally leak tested and it should be noted that a leak was observed on the horizon cassette in the window weld.Based on the evaluation results, the reported defect is confirmed.In order to address the issue of leakage within the cassette portion of the pump sets, b.Braun has initiated a corrective action/preventative action (capa 2021-007-pa) which provides for root cause analysis and corrective action.Additionally, as a result of this issue, b.Braun has initiated a voluntary medical device correction for multiple batches of outlook® pump sets including the batch identified from this complaint.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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