This report has been identified as b.Braun melsungen ag internal report # (b)(4).No sample has been returned for investigation.We received one photo of a discofix-3 blue.The photo shows a leakage.However, it cannot be determined from where the leakage has originated or what the root cause of the leakage is.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.The manufacturing documentation and machine papers have been checked.There are no deviation or entries noted which could lead to a failure as complained.Besides, 5 pcs retained samples have been visual checked as well.There are no abnormalities observed.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
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As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): serious adverse event.Discofix 3-way stopcock was used for infusion and pressure monitoring of icu patient.8 hours later it was found that the discofix was broken and liquid leaked.Vasoactive drug was not infused properly.Ventilator alarm showed patient's blood pressure decreased.The discofix was replaced immediately.After detection of the leakage, emergency treatment was given and the patient has recovered.Due to covid-19 pandemic, no sample available.
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