Model Number NIMBUS II PLUS |
Device Problems
Increase in Pressure (1491); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964); Pumping Problem (3016)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/07/2024 |
Event Type
malfunction
|
Event Description
|
On (b)(6) 2024, infutronix received a report that a pump had a flow rate issue during infusion, causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Dhr was reviewed, and the pump passed all previous tests.There are no previous complaints on this device.Pump was received on 02/21/2024.Analysis of the returned device was completed on 3/15/2024.The event log was reviewed, and it was found that an 100 ml infusion was stopped at a vinf of 4 after several upstream occlusion alarms.During functional testing, the reported problem could not be duplicated.
|
|
Search Alerts/Recalls
|