Model Number 456020 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 12/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number 400584376.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Event Description
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As reported by the user facility: details of complaint (reported issue): after turning patient, i assessed femoral line and saw the port running vasopressors was backing up with blood and saw the stopcock had disconnected and the luer was completely broken off.2 stop cocks replaced with this patient.Patient became hypotensive an meds had to be modified.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.Retained units were evaluated and passed the internal testing.A 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.Additionally, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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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Search Alerts/Recalls
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