NOVALUNG CONSOLE (LINUX BOARD)
Received Feb 16, 2026 · Event occurred Jan 30, 2026
Report 3012172416-2026-00011 · MDR key 24343285
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgModel number
NOVALUNG CONSOLE (LINUX BOARD)Catalog number
F30000162
Product problems
- Display or Visual Feedback Problem
- Output Problem
- Insufficient Device Problem Information
- No Visual Prompts/Feedback
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PLANT INVESTIGATION: NO PARTS WERE RETURNED FOR EVALUATION. THE SERIAL NUMBER OF THE CONSOLE AND SERIAL NUMBER OF THE FLOW SENSOR WERE UNKNOWN AS A REVIEW OF PREVIOUS COMPLAINTS AND/OR DEVICE REPAIR WAS NOT PERFORMED. THREE SIMILAR COMPLAINTS HAVE BEEN RECEIVED IN 24 MONTHS. THE AIR BUBBLE ALARMS WERE PROBABLY CAUSED BY A DEFECT IN THE FLOW MEASUREMENT SENSOR. THE PROBLEM WAS RESOLVED BY REPLACING THE SENSOR. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE NOVALUNG FLOW SENSING PROBE'S BUBBLE DETECTION FUNCTION IS TOO SENSITIVE AND CAUSING FALSE POSITIVE DEVICE ALARMS DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE USER STATED THAT NOVALUNG FLOW PROBE BUBBLE DETECTION FUNCTION CAUSED ALARM UPON INITIATION OF ECMO WITH NO EVIDENCE OF BUBBLES IN THE CIRCUIT. THE CLINICIAN TURNED BUBBLE DETECTION OFF TO CIRCUMVENT THE ALARM. BUBBLE DETECTION FUNCTION WAS TURNED BACK ON LATER DURING ECMO SUPPORT; HOWEVER, IT CONTINUED TO ALARM DURING THE NIGHT AND WAS AGAIN TURNED OFF. THE CLINICIAN REPLACED THE SUSPECT FLOW PROBE WITH A BACKUP FLOW PROBE WHICH RESOLVED THE ALARM ISSUE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION AS THE FACILITY WANTED TO RETAIN THE PRODUCT AS A BACKUP FLOW SENSOR.
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 THE NOVALUNG FLOW SENSING PROBE'S BUBBLE DETECTION FUNCTION IS TOO SENSITIVE AND CAUSING FALSE POSITIVE DEVICE ALARMS DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE USER STATED THAT NOVALUNG FLOW PROBE BUBBLE DETECTION FUNCTION CAUSED ALARM UPON INITIATION OF ECMO WITH NO EVIDENCE OF BUBBLES IN THE CIRCUIT. THE CLINICIAN TURNED BUBBLE DETECTION OFF TO CIRCUMVENT THE ALARM. BUBBLE DETECTION FUNCTION WAS TURNED BACK ON LATER DURING ECMO SUPPORT; HOWEVER, IT CONTINUED TO ALARM DURING THE NIGHT AND WAS AGAIN TURNED OFF. THE CLINICIAN REPLACED THE SUSPECT FLOW PROBE WITH A BACKUP FLOW PROBE WHICH RESOLVED THE ALARM ISSUE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION AS THE FACILITY WANTED TO RETAIN THE PRODUCT AS A BACKUP FLOW SENSOR.