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

Catalog Number	32000014
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported a hairline crack in the oxygenator and a slight blood leak that was observed in the two days after the start of extracorporeal membrane oxygenation support utilizing the xlung kit 230.The kit was replaced resulting in a blood loss of approximately 500 ml to 600 ml.The user administered one unit of packed red blood cells.There was no indication of significant consequence due to blood loss.The complaint sample was available for product evaluation.
Event or Problem Description
A user facility reported a hairline crack in the oxygenator and a slight blood leak that was observed in the two days after the start of extracorporeal membrane oxygenation support utilizing the xlung kit 230.The kit was replaced resulting in a blood loss of approximately 500 ml to 600 ml.The user administered one unit of packed red blood cells.There was no indication of significant consequence due to blood loss.The complaint sample was available for product evaluation.
Additional Manufacturer Narrative
Clinical review: upon follow-up with the xenios complaint manager, it was reported that this patient experienced a slight blood leak from a hairline crack on the oxygenator on (b)(6) 2026 during ecmo support.The xlung kit 230 was exchanged resulting in a blood loss of approximately 500 to 600 ml.The patient was provided with 250 ml of packed red blood cells because of the blood loss from the kit exchange.There was no indication that the patient experienced significant injury due to blood loss.The patient was able to continue with ecmo support following this event without incident.Blood replenishment is an essential practice of ongoing ecmo support due to either routine kit exchange as recommended by the manufacturer or other indications of lower than optimal blood volume.As the patient did not experience significant consequences because of blood loss that required blood replenishment, it can be concluded that this event was a temporary impairment requiring medical intervention.Based on the available information, there is no indication of a permanent impairment, patient death, or other that reported adverse event related to a xenios product or other issue, should additional information become available related to a fresenius device(s) and/or product(s), please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Additional information: d9 the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

• 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: 50816981
• Report Number: 3012172416-2026-00086
• Device Sequence Number: 18803658
• Product Code: QJZ
• UDI-Device Identifier: 04057224001494
• UDI-Public: 04057224001494
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 32000014
• Device Lot Number: GSXL1701
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Novalung Console (Linux Board); Novalung Console (Linux Board)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 220 LB