Model Number SL-2000M2095D |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/06/2022 |
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: event 6: customer reports issue with arterial line filling with air during blood return phase of dialysis and blood cannot be returned to the patient.This similar problem would occur if the line was not threaded properly, but in these cases, the arterial lines appear to be properly threaded, still air appears to enter the line.They are able to finish the treatment by clamping the a-line and bypassing.Approximately 100ml of blood is lost and not returned to the patient.No injury reported.
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Manufacturer Narrative
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Event 6: this report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation results, the root cause of the reported incident was unable to be determine.The actual defective device is a valuable tool in investigating the cause of this incident.A review of manufacturing records 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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