Model Number 25-28-67 |
Device Problem
Gas Output Problem (1266)
|
Patient Problem
Hypoventilation (1916)
|
Event Date 03/02/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Patient information was not provided.Livanova deutschland manufactures the s5 gas blender system.The incident occurred in bordeaux, france.Livanova initiated an investigation.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 gas blender system was used during a cardiac surgery on (b)(6) 2021.Reportedly, the pco2 value remained high despite user increasing the air/o2 flow to 4 liter/minute.The device was replaced with another and the user decreased the air/o2 flow rate and the pco2 value decreased to normal values.The immediate postoperative period was marked by hypoxemia with alveolar hypoventilation.The patient was released from hospital on (b)(6) 2021.
|
|
Event Description
|
See initial report.
|
|
Manufacturer Narrative
|
H.10: a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected device was returned to the manufacturer site.No errors and no deviations could be identified.However, the potentially involved component which is the mass flow controller for co2 was replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The involvement of the device cannot be ruled out and the most likely root cause of the event was a defective co2 mass flow controller.
|
|
Search Alerts/Recalls
|