Catalog Number SL-2000M2095 |
Device Problems
Device Alarm System (1012); Material Puncture/Hole (1504); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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: during treatment the tmp alarm was sounding off and during trouble shooting (before the system cut it off) the switched machines and changed the system.Treatment was continued.Treatment time was 180 and actual 176 minutes the same slit same shape and same length down the tubing was noted be slit.Treatment started at 6:15 and by 8:02 nurse noted the issued.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).No samples or photos were submitted to the manufacturer for evaluation.Retained samples were evaluated and no bubbles/air in line, tubing cut or kinks were observed during the examination.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.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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