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Model Number SL-2000M2095D |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2023 |
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: event 8: the pink dialyzer connection cap on arterial end of bloodline is fused shut or is so tight it cannot be opened.If the cap can be removed, it leaks.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).Event 8.A review of the manufacturing records for sl-2000m2095d, lot # 30155010 was performed and indicated there were no quality issues during the manufacturing of this lot.Although the shipment was delivered, the supplier stated the sample could not be located.If the sample does become available, the complaint will be reopened for further 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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