NOVALUNG CONSOLE (LINUX BOARD)
Received Apr 28, 2025 · Event occurred Mar 28, 2025
Report 3012172416-2025-00038 · MDR key 21922837
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
- Air/Gas in Device
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Air/Gas in Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A USER FACILITY REPORTED THAT A NOVALUNG CONSOLE SHOWED MULTIPLE "AIR BUBBLE DETECTED" ALARMS AFTER INITIATING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE USER COMPLETED ALL ROUTING TROUBLESHOOTING ACTIONS IN REGARD TO THE FLOW PROBE/BUBBLE DETECTOR WHICH DID NOT RESOLVE THE PROBLEM. THE USER EXCHANGED THE FLOW PROBE, AND THE REPLACEMENT PERFORMED AS EXPECTED. THE USER SUSPECTED THAT THE INITIAL FLOW PROBE WAS DEFECTIVE. THERE WAS NO INDICATION OF IMPACT TO THE PATIENT. IT WAS UNKNOWN WHETHER THE COMPLAINT SAMPLE WAS AVAILABLE FOR EVALUATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT A NOVALUNG CONSOLE SHOWED MULTIPLE "AIR BUBBLE DETECTED" ALARMS AFTER INITIATING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE USER COMPLETED ALL ROUTING TROUBLESHOOTING ACTIONS IN REGARD TO THE FLOW PROBE/BUBBLE DETECTOR WHICH DID NOT RESOLVE THE PROBLEM. THE USER EXCHANGED THE FLOW PROBE, AND THE REPLACEMENT PERFORMED AS EXPECTED. THE USER SUSPECTED THAT THE INITIAL FLOW PROBE WAS DEFECTIVE. THERE WAS NO INDICATION OF IMPACT TO THE PATIENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, H6 PLANT INVESTIGATION: NO COMPONENTS WERE RETURNED FOR EVALUATION. TWO SIMILAR COMPLAINTS WERE REPORTED IN THE LAST 24 MONTHS. THE SERIAL NUMBER OF THE CONSOLE AND SERIAL NUMBER OF THE FLOW SENSOR ARE UNKNOWN; THEREFORE, NO PRODUCTION RECORD REVIEW OF THE DEVICE WAS PERFORMED. THE AIR BUBBLE ALARMS WERE MORE THAN LIKELY CAUSED BY A DEFECT IN THE FLOW MEASUREMENT SENSOR. THE PROBLEM WAS RESOLVED BY REPLACING THE SENSOR. THE ISSUE WILL CONTINUE TO BE MONITORED.