Model Number 490105 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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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: it was reported via medwatch mw5102219, "bbraun y type blood infusion line had two breaks in the line that caused blood to spray.With loss of about 30 ml estimated.When blood transfusion was started.I witnessed part of the event, as well as inspected packaging for any obvious external damage or evidence of cutting into packaging.None found." 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 400521977. 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.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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