Model Number 456020 |
Device Problem
Degraded (1153)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/18/2022 |
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 (b)(4).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: description: during a gentle turn iv pump started alarming - upon inspection of lines we found the stopcock to have completely snapped, disconnecting all vasopressors and inotropes from central line.Broken stopcock quickly discarded, and life sustaining drugs quickly reconnected.This could have seriously impacted hemodynamics but also poses an infection rick to pt.No injury reported.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.A visual inspection confirms the spinlock broken off of the stopcock.Additionally, stress marks were observed at the point of breakage indicating excessive manual force was used to try and disconnect.Although the returned sample was damaged the defect could not be confirmed for a broken stopcock to be a result of any manufacturing/packaging process.While an exact root cause cannot be determined, a review of the complaint sample suggests that the breakage did not originate from a failure in the manufacturing process.Based on these findings the most likely potential cause is that the defect originated from the excessive force being placed on the valve during use.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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Search Alerts/Recalls
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