Catalog Number SL-2000M2095L |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2023 |
Event Type
malfunction
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Event Description
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As reported by the user facility: event 1: brief inquiry description.Small slice/cut noted in blood pump segment of tubing.Detailed inquiry description the blood pump segment of arterial line has a small slice / slight cut in the tubing.Not noticeable until the patient gets on the machine.Customer reports two occurrences with two different machines at (b)(6) hospital and the customer doesn't feel comfortable using the inventory from the affected lot# at this facility.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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This report has been identified as b.Braun medical internal report number (b)(4).Event 1 a device history record (dhr) review 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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