Model Number NIMBUS II PLUS |
Device Problems
Mechanical Problem (1384); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2024 |
Event Type
malfunction
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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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Event Description
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On 02/17/2024, 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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Dhr was reviewed, and the pump passed all previous tests.There is one previous complaint on this device for constant upstream occlusion alarms.Pump was received on 2/29/2024 and tested on 2/29/2024.The results are below: the event log was pulled for review before the device was tested and there were no lines that indicated a system error took place.A test infusion was then started, and right away the pump alarmed system error.The event log was pulled for review again, and now there lines for a system error present.The lines had a subcode of 44 which indicates motor open, motor delay issue.The reported issue is confirmed.The pump does not meet passing criteria.
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Search Alerts/Recalls
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