Catalog Number SL-2000M2095 |
Device Problems
Leak/Splash (1354); Detachment of Device or Device Component (2907)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 09/21/2023 |
Event Type
malfunction
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Event Description
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As reported by the user facility: brief inquiry description: blood tubing segment separation-post pump.Detailed inquiry description: issue with separation post blood tubing segment.Significant blood drip below the blood pump, identified at the junction between the blood pump segment and the thinner segment of lines opposite "bubble" end.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).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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.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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