Model Number 60-01-00 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/21/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp displayed error messages during set-up.There was no patient involvement.
|
|
Event Description
|
See initial report.
|
|
Manufacturer Narrative
|
A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to defective device.The technician replaced the erc clamp to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The defective device was requested back to livanova deutschland for further investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
See initial.
|
|
Manufacturer Narrative
|
The device was returned livanova deutschland for further investigation.During the evaluation the reported issue could be confirmed and reproduced.Fluid ingress inside the clamp could be identified as root cause for the reported issue.This is a known issue and livanova deutschland implemented corrective actions to solve the reported issue.
|
|
Search Alerts/Recalls
|