Model Number SL-2010M2096 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as event 1 of b.Braun medical inc.Internal report number (b)(4).The device involved has not been received for evaluation and 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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Event 1: as reported by user facility: when reinfusion blood to patient at the end of treatment sediment was noted in the venous bloodline.Patient was asymptomatic and no injuries reported.
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Manufacturer Narrative
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This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 1.One (1) bloodline set was received by the manufacturer for evaluation in conjunction with this complaint.The blood set was visually inspected and appeared to have been rinsed as there was no sediment observed in the line.A review of the device history records for sl-2010m2096 lot: 00754022 was performed and it indicated there were no quality issues during the manufacturing process of this lot related to the reported issue.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The reported defect could not be confirmed.If additional pertinent information becomes available a follow-up report will be filed.
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Search Alerts/Recalls
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