Model Number 601238 |
Device Problems
Labelling, Instructions for Use or Training Problem (1318); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2021 |
Event Type
malfunction
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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).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 per reported by the user facility: the infusion rate on the label is not updating appropriately after updating the patient's weight.When the provider updates the patient's weight but does not change the ml/kg infusion volume, the total infusion volume (ml) appropriately changes, however the ml/hr infusion rate does not update.There was no patient involvement.
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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).This is an anomaly in the software where the patient weight changes on /kg orders do not automatically force a re-calculation of the infusion rate.This can lead to an incorrect infusion rate being printed on the final container label.This software anomaly will be addressed in apex project 20200211.The workaround is, after changing the rate, any orders that are not yet authorized should have their rate deleted and then submit changes to re-calculate the rate.It will then re-calculate the rate correctly.If additional pertinent information becomes available a follow-up report will be filed.
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Search Alerts/Recalls
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