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Model Number SL-2010M2096A |
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 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: during set up the arterial line is coming of the pump and the tubing was not attached, there was no adhesive holding everything together.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).Three (3) unused samples with packaging were returned for evaluation.The samples were visually evaluated and functionally leak tested, and it was noted two of the three samples were leaking from the cap of the pump segment which was found to be a bonded joint.Under magnification, it was noted that the tubing was clean of solvent.Based on the visual evaluation of the samples returned the reported defect of detachment was confirmed.Incidents of this nature are attributed to operator oversight during the solvent application process.Although our training procedures ensure that all employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.As a result of this occurrence a quality notification and retrain was generated for all associates involved in the hand assembly process.Retained units were evaluated and passed the internal testing.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.
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Search Alerts/Recalls
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