Model Number SL-2010M2096 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2022 |
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: detailed inquiry description: during setup the blue dialyzer connector detached from the bloodline.No patient involvement.
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Manufacturer Narrative
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This report is being submitted as a correction for report number (b)(4).The incorrect batch number was noted.This follow up notes the correct batch number.Please see below.A review of manufacturing records for sl-2010m2096 lot a2200261 was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).Three photos were provided for further evaluation.A visual evaluation was performed on the photographs and it was noted that the filter connector of the venous line was detached from the set.It is quite difficult to determine if there is any solvent at the end of the tubing without a physical sample to evaluate.Based on the evaluation results, the reported defect of detachment was confirmed.A quality alert was created to notify the personnel involve and provide training to aid in the "solvent application method".A review of manufacturing records for sl-2010m2096 lot 20254011 was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.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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