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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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Event Description
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As reported by the user facility: event 1: detailed inquiry description: 3 incidents where during treatment, air in lines, after connecting to the patient.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).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Manufacturer Narrative
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Event 1: this report has been identified as b.Braun medical internal report number (b)(4).While no sample was returned, multiple photos were submitted to the manufacturer for evaluation.Through visual inspection of the photographs, it was observed that the reported issue is confirmed as air is shown in the arterial line.Without the sample to evaluate the exact cause could not be determined.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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