Model Number SL-2000M2095D |
Device Problems
Leak/Splash (1354); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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As reported by the user facility: event 2 : description: venous side of lines are molded shut and were partly open when put on dialyzer will leak blood.The venous port is the problem.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 400603597.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).Event 2.A review of the manufacturing records for sl-2000m2095d lot # 30155006 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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