|
Model Number 382400 |
Device Problem
Inaccurate Flow Rate (1249)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/22/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
|
|
Event Description
|
The customer reported that the device was pumping beyond the specified rate.There was no harm to the patient.
|
|
Manufacturer Narrative
|
An evaluation of the kangaroo pump was performed.The unit underwent several tests including: dislodged alarm crimp tube test, bag empty alarm mistic test, rotor test, occlusion test and accuracy test.The unit passed all tests.The reported issue was unable to be confirmed at this time.The power connection label was replaced due to opening the unit and the unit¿s software was reinstalled.No further actions are required at this time.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
|
|
Search Alerts/Recalls
|
|
|