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	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/20/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between ecmo support utilizing the novalung console and the patient¿s severe hypotension that required a support modality change.The patient¿s hypotension can be attributed to a consequence of a severe viral infection with respiratory failure involving both influenza types a and b as reported by a medical professional.A temporal relationship does not exist between the patient¿s death as they were removed from support before succumbing to respiratory failure in the environment of a severe viral infection.It is well established critically ill patients on ecmo support carry a high risk of mortality due to underlying pathology and/or the patient¿s response to ecmo support.It was reported that the patient¿s viral infection leading to respiratory failure with hypotension, the associated hospitalization, clotting of the competitor crrt device and the patient¿s subsequent death were not the result of a deficiency or malfunction of any xenios product(s) or device(s).Therefore, the novalung console can be excluded as the source of this patient¿s adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A clinical support specialist reported that this 70-year-old female critically ill patient was status-post coronary arterial bypass graft procedure on (b)(6) 2025 who was discharged home and developed severe respiratory failure.Emergency medical services transported the patient to the hospital on (b)(6) 2026 where they tested positive for influenza types a and b.The patient was cannulated for veno-venous extracorporeal membrane oxygenation (ecmo) support on (b)(6) 2026 and experienced severe hypotension in the early morning of (b)(6) 2026 while on support.It was explained that initial reports of cardiac arrest were false as the patient instead experienced severe hypotension that required a change in ecmo modality for cardiopulmonary support.As a result, the patient was transitioned to veno-venoarterial ecmo support on the same device and patient circuit.The patient received multiple blood products and continuous renal replacement therapy (crrt) with a prismax device (not a fresenius/xenios product) that was initiated for renal support.The filter of the competitor crrt device clotted and was changed out that morning.Plasma free hgb levels were checked and resulted at greater than 500 mg/dl after receiving various blood products.It was determined by the user facility that the clotting of the crrt device was from multiple blood products and unrelated to the performance of the novalung console or associated xenios products.Ecmo support was discontinued by decision of the family on the evening of (b)(6) 2026, and the patient subsequently expired approximately two hours following discontinuation of support.It was reported that the patient¿s viral infection leading to severe hypotension and respiratory failure, the associated hospitalization, clotting of the competitor crrt device and the patient¿s subsequent death were not the result of a deficiency or malfunction of any xenios product(s) or device(s).The css reported that no xenios products will be returned for evaluation and the same novalung device was primed and utilized for a different patient the following day without incident.
Additional Manufacturer Narrative
Additional information: h6 clinical review: a temporal relationship exists between ecmo support utilizing the novalung console and the patient¿s severe hypotension that required a support modality change.The patient¿s hypotension can be attributed to a consequence of a severe viral infection with respiratory failure involving both influenza types a and b as reported by a medical professional.A temporal relationship does not exist between the patient¿s death as they were removed from support before succumbing to respiratory failure in the environment of a severe viral infection.It is well established critically ill patients on ecmo support carry a high risk of mortality due to underlying pathology and/or the patient¿s response to ecmo support.It was reported that the patient¿s viral infection leading to respiratory failure with hypotension, the associated hospitalization, clotting of the competitor crrt device and the patient¿s subsequent death were not the result of a deficiency or malfunction of any xenios product(s) or device(s).Therefore, the novalung console can be excluded as the source of this patient¿s adverse events.Plant investigation: no similar complaints have been reported concerning the novalung console.There were no allegations of defects or malfunctions in the console as a repair history and/or machine files were not required for evaluation.No parts were available for evaluation.As no malfunction or deficiency was identified, there was no additional health risk identified.
Event or Problem Description
A clinical support specialist reported that this 70-year-old female critically ill patient was status-post coronary arterial bypass graft procedure on (b)(6) 2025 who was discharged home and developed severe respiratory failure.Emergency medical services transported the patient to the hospital on (b)(6) 2026 where they tested positive for influenza types a and b.The patient was cannulated for veno-venous extracorporeal membrane oxygenation (ecmo) support on (b)(6) 2026 and experienced severe hypotension in the early morning of (b)(6) 2026 while on support.It was explained that initial reports of cardiac arrest were false as the patient instead experienced severe hypotension that required a change in ecmo modality for cardiopulmonary support.As a result, the patient was transitioned to veno-venoarterial ecmo support on the same device and patient circuit.The patient received multiple blood products and continuous renal replacement therapy (crrt) with a prismax device (not a fresenius/xenios product) that was initiated for renal support.The filter of the competitor crrt device clotted and was changed out that morning.Plasma free hgb levels were checked and resulted at greater than 500 mg/dl after receiving various blood products.It was determined by the user facility that the clotting of the crrt device was from multiple blood products and unrelated to the performance of the novalung console or associated xenios products.Ecmo support was discontinued by decision of the family on the evening of (b)(6) 2026, and the patient subsequently expired approximately two hours following discontinuation of support.It was reported that the patient¿s viral infection leading to severe hypotension and respiratory failure, the associated hospitalization, clotting of the competitor crrt device and the patient¿s subsequent death were not the result of a deficiency or malfunction of any xenios product(s) or device(s).The css reported that no xenios products will be returned for evaluation and the same novalung device was primed and utilized for a different patient the following day without incident.

• 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: 24266913
• Report Number: 3012172416-2026-00004
• Device Sequence Number: 13443247
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/04/2026
• 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 Age: 70 YR
• Patient Sex: Female