Catalog Number SL-2000M2095L |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
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).Event 5 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 5 brief inquiry description venous pod dysfunction - breakthrough detailed inquiry description customer reports at least five incidents of blood and/or saline breakthrough noted by clinical team to machine from venous pressure monitoring line.Upon investigation, customer noted that there is not a diaphragm in one of the venous pods.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 5.A review of the device history record (dhr) 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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