NOVALUNG CONSOLE (LINUX BOARD)
Received Jun 8, 2026 · Event occurred May 22, 2026
Report 3012172416-2026-00046 · MDR key 25426841
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgModel number
NOVALUNG CONSOLE (LINUX BOARD)Catalog number
F30000162
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT DURING THE DAYS BEFORE THE EVENT, MORE AND MORE VIBRATIONS WERE AUDIBLE FROM THE PUMP. SEVERAL TIMES, THE ERROR CODE '225' WAS DISPLAYED DURING THE NIGHT OF THE EVENT, AND ONCE BEFORE WITH ERROR CODE '00A'. DURING THE NIGHT, THE CONSOLE STOPPED WORKING AND THE USER SWITCHED TO EMERGENCY MODE. ALL CONNECTIONS WERE CHECKED AND THE PLUG OF THE PUMP DRIVE WAS FOUND TO BE LOOSE. IT WAS FIXED AND THE CONSOLE WAS STARTED AGAIN. ON THE NEXT MORNING (23RD), AT 9:18 A.M., THE CONSOLE SHUT DOWN ONCE AGAIN DISPLAYING ERROR CODE '225'. AFTER THIS, THE SYSTEM WAS SWITCHED TO ANOTHER CONSOLE AND CONTINUES TO WORK WITHOUT ISSUE AT EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT SETTINGS AT A BLOOD FLOW RATE OF 5L/MIN AT 7300 RPM AND 18 W. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.