Model Number NIMBUS II PLUS |
Device Problems
Mechanical Problem (1384); Failure to Infuse (2340); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
malfunction
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Event Description
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On (b)(6) 2024, infutronix received a report that a pump stopped infusing due to a system error alert.The infusion cannot resume without causing delay in treatment.Requested device to be returned.
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Manufacturer Narrative
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A review of the device history record has been completed.The pump passed all previous tests.Complaint data was reviewed, there are no previous complaints on this device.Device return requested.This mdr will be reopened and updated in the event the device involved or additional information becomes available.
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Manufacturer Narrative
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Analysis of the returned device was completed on 3/25/2024.The results are below: the event log was reviewed, and it was confirmed that the pump alarmed system error during an infusion.It took place 5 ml's into a 20 ml infusion.Subcode 44 indicates motor open, motor delay issue.Subcode 24 indicates motor is fast, motor delay issue.During functional testing, the reported problem was duplicated.A 20 ml infusion was started and the pump alarmed system error right away.
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Search Alerts/Recalls
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