LIVANOVA DEUTSCHLAND HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 16-02-85 |
Device Problem
Temperature Problem (3022)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/30/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.As per field service engineer, patient pumps need to be replaced.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 heater-cooler system 3t displayed error code "pump is blocked or too slow" (error e07) during maintenance.There was no patient involvement.
|
|
Event Description
|
See initial report.
|
|
Manufacturer Narrative
|
H10: through follow-up communication livanova learned that the error message associated to pump was on patient side of the heater cooler 3t system.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to fix it, stirrer motor was replaced.In addition, during repair it was noted that patient pumps were noisy, therefore the were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2015.The symptoms (noisy and stuck motors) found by the livanova technician on the replaced components are related to a mechanical fault.The most likely root cause of the reported issue is associated to motor bearing damaged by the corrosion, which consequently does not allow the motor shaft to rotate.Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.Causes related to environmental conditions.
|
|
Search Alerts/Recalls
|
|
|