MAUDE Adverse Event Report: XENIOS AG NOVALUNG CONSOLE (LINUX BOARD); EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE

Model Number	NOVALUNG CONSOLE (LINUX BOARD)
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005); Insufficient Device Problem Information (3190); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
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
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.
Event or Problem Description
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.

• Brand Name: NOVALUNG CONSOLE (LINUX BOARD)
• Common Device Name: EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE
• Manufacturer (Section D): XENIOS AG; director of quality; im zukunftspark 1; heilbronn baden-wurttemberg 74076 ; GM 74076
• Manufacturer (Section G): XENIOS AG; director of quality; im zukunftspark 1; heilbronn baden-wurttemberg 74076 ; GM 74076
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 24343285
• Report Number: 3012172416-2026-00011
• Device Sequence Number: 9541193
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NOVALUNG CONSOLE (LINUX BOARD)
• Device Catalogue Number: F30000162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XLUNG KIT (USA).; XLUNG KIT (USA).
• Patient Sex: Unknown