MAUDE Adverse Event Report: XENIOS AG XLUNG KIT (USA); EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE

Catalog Number	F32000004
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	05/11/2026
Type of Reportable Event	Death
Event or Problem Description
A user facility reported a loud noise heard during support coming from the pump head.A nurse notified the clinical specialist of the novalung making a loud noise.The nurse recorded the event.The patient was on support for approximately 5 days while no complications were encountered, ldh levels were within normal range and consistent throughout support.The patient was significantly ill while exhibiting multi-organ failure prior to initiation of extracorporeal membrane oxygenation support as a last effort to try and turn their condition around.The patient ultimately succumbed to their illness secondary to a significantly ischemic bowel.Support was withdrawn when efforts became futile.The complaint sample was not available for product evaluation.

• Brand Name: XLUNG KIT (USA)
• 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
• MDR Report Key: 25468952
• Report Number: 3012417381-2026-00004
• Device Sequence Number: 16028932
• Product Code: QJZ
• UDI-Device Identifier: 04057224001494
• UDI-Public: 04057224001494
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026
• Report Date (Section F): 06/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: F32000004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2026
• Device Age: MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOVALUNG CONSOLE (LINUX BOARD).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown