As reported by the user facility: details of complaint (reported issue): stopcock leaking onto pillow (lumen that was infusing pressor and sedation medications) and patient blood pressure dropped with interruption of infusion.Pt repositioned in bed.Blood pressure (down arrow) thereafter, initially thought related to repositioning.Write increased pressor medication dose with no affect.On further inspection, stopcock leaking onto pillow (lumen that was infusing pressor and sedation medication).Pt was on high dose pressors - bp dropped to ~79/41 (50) with interruption of infusion.
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This report has been identified as b.Braun medical internal report number (b)(4).Three (3) samples were provided for evaluation.The samples were subject to a visual evaluation.Two of the three sample passed the visual evaluation.The third sample was visual evaluated and failed.Upon testing the sample per specification, a leak/crack was observed on the top port of the discofix.A visual investigation of the sample was performed by the manufacturing site it was detected a crack in the lli-cone.While an exact root cause cannot be determined, review of the complaint samples and manufacturing records suggests that the defect did not originate from a failure in the manufacturing processes.Based on these findings the most likely potential cause is that the defect originated from excessive force being placed on the valve during use.Please note a probable root cause for cracks in the lli-cone could be high tensions in combination with disinfectants and / or certain drug ingredients (oil, alcohol, lipids etc.).Because of this, we assume of a problem during the application process.Retained units were evaluated and passed the internal testing.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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