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	Device Alarm System (1012); Protective Measures Problem (3015); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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 an 'error 208' alarm that occurred approximately 18 hours after turning on the console and during priming for extracorporeal membrane oxygenation support.There was no patient involvement.The complaint sample will not be returned for product investigation as the device will be addressed onsite.
Additional Manufacturer Narrative
Additional information: d1 plant investigation: the log data of console xen0276 from (b)(6) 2025, at 03:42 (all times local) to (b)(6) 2025, 21:45 were provided by the user facility.The console started on (b)(6) 2025, at 03:42.At 03:43, the pump speed was set to 2000 rpm, resulting in a flow rate of approximately 1 l/min.Until alarm 208 occurred at 21:50, there were no abnormalities and no further alarms occurred.The alarm occurred for no apparent reason.Subsequently, no flow measurement was displayed until the end of the recording.No parts were returned for evaluation as the console was checked onsite by the fresenius/xenios technical service team.No abnormalities were found at the console during an onsite evaluation.A functional check and electrical safety check were performed.During testing, the failure could not be reproduced, and no defect was found at the console.The flow board in the sensor box was replaced as a preventive measure.
Event or Problem Description
A user facility reported an 'error 208' alarm that occurred approximately 18 hours after turning on the console and during priming for extracorporeal membrane oxygenation support.There was no patient involvement.The complaint sample will not be returned for product investigation as the device will be addressed onsite.

• 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: 23777122
• Report Number: 3012172416-2025-00114
• Device Sequence Number: 10091823
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/12/2026
• 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
• Patient Sex: Unknown