Model Number 383400 |
Device Problem
Excess Flow or Over-Infusion (1311)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/07/2021 |
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.
|
|
Event Description
|
The customer reported that the device flow was not conforming.Additional information was provided stating that the issue happened during the reconditioning test.The device flowed faster than the set rate.No further information was provided.
|
|
Manufacturer Narrative
|
H3 evaluation summary: the service history record was reviewed.The unit was 100% functional at the time of last release after preventative maintenance.The customer reported the flow is not conforming.The reported issue was not able to be duplicated, the issue could not be confirmed.No action was found necessary as the reported condition could not be duplicated.This complaint will be used for tracking and trending purposes.
|
|
Search Alerts/Recalls
|