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

Catalog Number	F30000162
Medical Device Problem Codes	Infusion or Flow Problem (2964); No Flow (2991); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 a patient who had been receiving support on another device was connected to the novalung console on (b)(6) 2026 between 1300 and 1400 (local time), which was already primed.The user reported that the main pump did not operate, and no flow value was displayed on the console.Due to the main pump issue, an attempt was made to continue support by connecting the auxiliary pump and battery pack.The auxiliary pump also failed to operate, and support could not be continued.The user requested further verification to determine whether the issue was caused by a device malfunction or by user operation.During the local device inspection, no abnormal symptoms or malfunctions were found.There was no patient serious injury resulting.The complaint sample was not available for product evaluation.
Additional Manufacturer Narrative
Additional information: b5, h6 plant investigation: no non-conformity was observed during the manufacturing process, and no other complaints have been reported about this device.The review of the repair history in the qtrak complaint amd system of the console 5xul2057 showed three repair activities related to this complaint.Upon onsite inspection of the device and review of machine files, it was found that no failure of the drives or device malfunction can be seen in the log data of the console.The data shows that the drive is functional and changes the speed depending on the setting.The pump drive's power consumption changes depending on the speed.In addition, corresponding changes can be observed in the readings from the pressure sensors.However, the measured flow does not seem to change accordingly.Probable causes for the observed issue and flow values in the data may be a defect of the flow sensor or an obstruction like a clamped tube.No defects were found in the flow sensor or any components of the console, and the problem could not be reproduced.No failure of the drives or device malfunction can be seen in the data.As a result, a definitive cause could not be confirmed.
Event or Problem Description
A user facility reported that a patient who had been receiving support on another device was connected to the novalung console on 19/feb/2026 between 1300 and 1400 (local time), which was already primed.The user reported that the main pump did not operate, and no flow value was displayed on the console.Due to the main pump issue, an attempt was made to continue support by connecting the auxiliary pump and battery pack.The auxiliary pump also failed to operate, and support could not be continued.The user requested further verification to determine whether the issue was caused by a device malfunction or by user operation.There was no patient serious injury resulting.The device and machine data log files were investigated onsite at the user facility by technical support.

• 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: 24567803
• Report Number: 3012172416-2026-00022
• Device Sequence Number: 15545156
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/31/2026
• 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 230; XLUNG MINILUNG
• Patient Sex: Unknown