MAUDE Adverse Event Report: Xenios AG XLUNG Kit 230; Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure

Catalog Number	32000014
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
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 on the morning of (b)(6) 2026, a significant puddle was observed at the base of the machine, and the xlung kit tray was filled with fluid.The exact source of the leak could not be identified; however, upon opening the tray, one of the tubes connected to the 3/8" fitting appeared to be insufficiently inserted.It should be noted that as the circuit was full of air the pump head was damaged during operation.The circuit therefore had to be replaced.There was no patient involvement.The complaint sample was available for product evaluation.

• Brand Name: XLUNG Kit 230
• 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 ; +1(617)417-5172
• MDR Report Key: 25592888
• Report Number: 3012172416-2026-00053
• Device Sequence Number: 20258867
• Product Code: QJZ
• UDI-Device Identifier: 04057224001494
• UDI-Public: 04057224001494
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/22/2026

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: 32000014
• Device Lot Number: GSXI0103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown