Catalog Number SL-2000M2095 |
Device Problems
Material Puncture/Hole (1504); Air/Gas in Device (4062)
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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: event 10.Brief inquiry description.Cuts noted in blood pump segment.Detailed inquiry description.Approximately 10 incidents of cuts noted in blood pump segments noted over last 2 months.Per the original report: while starting a treatment, machine kept alarming due to air entering line.Large amounts of air continued to enter tubing.Tubing changed.Upon investigation it was due to holes in the tubing above the non-invasive pressure monitor pod - arterial.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).Event 10 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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