Model Number INFKIT2 |
Device Problem
Failure to Auto Stop (2938)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/11/2022 |
Event Type
malfunction
|
Event Description
|
The initial reporter stated that the pump under infused and that it also did not stop when it was done.They stated that it was pumping air.Mmdg did follow up with the initial reporter to obtain addition information.The initial reporter stated that the patient did not experience any adverse effects due to the complaint.(b)(4).
|
|
Manufacturer Narrative
|
This device was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.Because the device was not returned to mmdg, no investigation could be completed.This report will be updated if the device is returned to mmdg.This report is being filed because there is indication that the event occurred while the device was in use by a pediatric patient (under 18).Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.
|
|
Manufacturer Narrative
|
This device was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.When the device was returned to mmdg for investigation, it operated as expected.Mmdg could not replicate or confirm the reported complaint.This report is being filed because there is indication that the event occurred while the device was in use by a pediatric patient (under 18).Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.
|
|
Event Description
|
The initial reporter stated that the pump under infused and that it also did not stop when it was done.They stated that it was pumping air.Mmdg did follow up with the initial reporter to obtain addition information.The initial reporter stated that the patient did not experience any adverse effects due to the complaint.[complaint- (b)(4).
|
|
Search Alerts/Recalls
|