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	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that during the assembly and priming of the support device, the priming solution leaked through the ports for the thermal unit.The oxygenator membrane was damaged, so the circuit was therefore unusable.There was no patient involvement.The complaint sample was not available for product evaluation.
Additional Manufacturer Narrative
Plant investigation: it was reported that during priming of the xlung kit 230, priming solution leaked out of the ports of the thermal unit.As the oxygenator membrane was found damaged and unusable, the kit was replaced.A review of the batch documentation revealed no non-conformities during the manufacturing process.No other similar complaint has been reported about this batch number.A definite cause of the leak could not be determined.Based on the description, possible causes could be a defect in the heat exchanger mat or a defect in potting of the heat exchange cylinder.Although our oxygenators are 100% leak tested, in a few cases leakage may occur due to adverse environmental conditions or mechanical stress.

• 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 ; 6174175172
• MDR Report Key: 25484357
• Report Number: 3012172416-2026-00048
• Device Sequence Number: 9734958
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: 32000014
• Device Lot Number: GSXH0416
• 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: 05/26/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2025
• 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