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	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported an issue that occurred between (b)(6) 2026.During extracorporeal membrane oxygenation support, the rpms of the pump were reduced without a change to the console.The user exchanged the patient xlung kit 230.The user reported a coagulation issued on the side of the patient.The customer was concerned about the potential for a technical issue.A clinical support specialist was onsite and explained the formation of a clot was the probable cause for the rpm reduction.Technical services were onsite and checked the machine to rule out a technical failure.No technical issue was found but the field team.There was no patient serious injury.The complaint sample was available for product evaluation.
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 issue that occurred between (b)(6) 2026.During extracorporeal membrane oxygenation support, the rpms of the pump were reduced without a change to the console.The user exchanged the patient xlung kit 230.The user reported a coagulation issue on the side of the patient.The customer was concerned about the potential for a technical issue.A clinical support specialist was onsite and explained the formation of a clot was the probable cause for the rpm reduction.Technical services were onsite and checked the machine to rule out a technical failure.No technical issue was found but the field team.There was no patient serious injury.The complaint sample was not received by the manufacturer; however, machine logfiles were provided by the user facility.
Additional Manufacturer Narrative
Additional information: b5, h4 plant investigation: nonconformity was not observed during the manufacturing process.No other complaints have been reported about this device, and a review of repair history was not conducted.The log data of console (b)(6) from (b)(6) 2025, to (b)(6) 2026, were provided.No defect was found at the console.The log data of the console indicated recurrent drainage cannula suction events during the course of support from (b)(6) 2025, to (b)(6) 2026.On (b)(6) 2026, the data indicated a significant increase in pump mechanical load with persistent elevated power consumption, which was suggestive of increased mechanical resistance within the pump head, potentially due to thrombus formation.

• 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: 24267274
• Report Number: 3012172416-2026-00006
• Device Sequence Number: 10021501
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• 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 Catalogue Number: F30000162
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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 KIT 230.
• Patient Sex: Unknown