LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 10-80-00 |
Device Problem
Pumping Stopped (1503)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in rochester, minnesota.Through follow-up communication livanova learned that the error message was persistent even after unit reboot.In order to solve the issue motor control board was replaced by a hospital biomedical engineer.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
Livanova deutschland received a report that a s5 roller pump gave a motor controller failure error message at setup.There was no patient involvement.
|
|
Manufacturer Narrative
|
H10: complaints database analysis revealed no other events since unit installation in 2006.Based on the information collected, it cannot be excluded that an electrical/electronic deviation due to wear of the replaced component was the root cause of the reported issue.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro sub-components.
|
|
Event Description
|
See initial report.
|
|
Search Alerts/Recalls
|
|
|