Catalog Number 4540018-02 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
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 6.Brief inquiry description: easypump infusing faster than intended.Detailed inquiry description was contacted by director of pharmacy.She said that they have had at least 7 infusions with easypump finish within a 24 hr window (about twice as fast as intended) over the last 2 weeks.The total amount of easypump therapies delivered in this time period was 24.We reviewed preparation protocols and patient education.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 400648720.Event 6 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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