Model Number NIMBUS II PLUS |
Device Problems
Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/17/2024 |
Event Type
malfunction
|
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.
|
|
Event Description
|
On 07/18/2024, infutronix received a report that a pump had a 'flow rate issue-under infusing", causing loss of infusion parameters.The infusion cannot resume without causing delay in treatment.Requested device to be returned.
|
|
Manufacturer Narrative
|
Dhr was reviewed, and the pump passed all previous tests.There are previous complaints on this device.Analysis of the returned device was completed on (b)(6) 2024: the pump was tested with the testing protocol for flow rate.The initial bottle weight was recorded at 85.074 g before the 100 ml infusion, and 177.023 g after the infusion, which has a total weight of 91.949 g and a deviation of (b)(4).The pump is out of range and not performing to specification, which is (b)(4).The pump ran at a rate of 99 ml per hour and a vtbi of 100 ml, keeping the current customer's parameter for the rate.Reported issue found, device not performing to specification.This complaint has been reviewed, evaluated, and determined to be a part of capa # it2022-06.The corrections made were in section b5- there was no loss of parameters and the date that was listed initially was incorrect.
|
|
Event Description
|
On (b)(6) 2024, infutronix received report of a pump that had a flow rate issue and was "under infusing".The issue was found during testing, there was no patient involvement.The device was returned.
|
|
Search Alerts/Recalls
|