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Catalog Number SL-2010M2096A |
Device Problem
Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/31/2023 |
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).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: detailed inquiry description: (b)(6) 2023 rps stopped in unit to introduce self to staff the afternoon before scheduled day for dialog, sl, adimea review.As i was speaking with the charge nurse, (b)(6), i noticed blood in the venous pod monitor line of the pt running directly across from nurses station.Upon investigation the blood in line was confirmed and blood was all the way to the machine.Treated as blood leak and pt not rinsed back.Estimated blood loss ~ 200ml.Patient still had just over 1/2 tx to run.He completed tx on a new circuit on a different machine.Received 1gm vancomycin ivpb d/t blood leak.Completed tx and left clinic w/no adverse effects noted 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).One contaminated sample was provided by the facility for evaluation.The sample was visually evaluated, and it was noted there was blood in the transcluded line on the venous line, it was observed the pod was in an upward position.Due to heavy contamination, the sample was not able to be decontaminated.Based on the evaluation the reported defect is not confirmed to be a manufacturing defect.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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