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

Catalog Number	32000014
Medical Device Problem Codes	Infusion or Flow Problem (2964); Air/Gas in Device (4062)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/01/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Clinical review: a temporal relationship does not exist between ecmo support utilizing the xlung kit 230 and the patient¿s cardiac arrest leading to their death as ecmo could not be initiated due to a de-primed patient circuit.The cause of this patient¿s cardiac arrest was not reported; however, the patient¿s death can be attributed to a poor prognosis and the inability to initiate ecmo support.It is well known that patients who require ecmo support have a significantly high risk for mortality following out-of-hospital cardiac arrests with the need for ecmo-assisted cpr (1).The reason for the de-primed circuit and the inability to establish flows was unknown.There were no reports of any leaks previously noted from the circuit or visible damage to any component of the xlung kit.As a product investigation has not been conducted prior to this reporting and the source of the malfunction of the oxygenator remains unknown, the xlung kit 230 cannot be excluded as a potential source or contributor to 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 user facility reported that the patient circuit was deaired during the day without any issues in preparation for a possible emergency.A patient was transferred to the cardiology department while cardiopulmonary resuscitation (cpr) was being performed.The perfusionist was not available to connect the patient as she was occupied in the operating room with a surgical procedure.The machine was brought down with the pump running in order to keep the circuit under pressure.At the time of connecting the patient, who was still receiving cpr, the circuit was full of air, the pump head was making significant noise and was unable to deliver an adequate flow.The perfusionist arrived but was unable to initiate extracorporeal membrane oxygenation support.As the facility weas unable to connect the patient, who was cannulated and still receiving cpr, the decision was made to stop resuscitation, and the patient was declared deceased.The pump head appears to be damaged, likely because it was de-primed.The complaint sample was available for product evaluation.
Event or Problem Description
A user facility reported that the patient circuit was deaired during the day without any issues in preparation for a possible emergency.A patient was transferred to the cardiology department while cardiopulmonary resuscitation (cpr) was being performed.The perfusionist was not available to connect the patient as she was occupied in the operating room with a surgical procedure.The machine was brought down with the pump running in order to keep the circuit under pressure.At the time of connecting the patient, who was still receiving cpr, the circuit was full of air, the pump head was making significant noise and was unable to deliver an adequate flow.The perfusionist arrived but was unable to initiate extracorporeal membrane oxygenation support.As the facility was unable to connect the patient, who was cannulated and still receiving cpr, the decision was made to stop resuscitation, and the patient was declared deceased.The pump head appeared to be damaged, likely because it was de-primed.The complaint sample was received for product evaluation.
Additional Manufacturer Narrative
Additional information: a2, a3, b5, d4, d9, h3, h6.Plant investigation: nonconformity was not observed during the manufacturing process.No similar complaints have been reported about this batch number.According to the log data of the console, the system was circulating for several hours at 2200 rpm until it was transported to the catheterization lab on (b)(6) 2026, likely at 6:14 pm (all times local).In the data, the blood flow drops at 7:08 pm without any prior abnormalities.At 7:13 pm, the speed increased (from 2200 rpm to 4200 rpm), and the power consumption rose accordingly.Starting at 7:15 pm, the power consumption increased more sharply (up to 14 w at 3,500 rpm).Power consumption increased significantly after this incident, with barely any flow and moderate speed.This is consistent with the description of air in the system, and almost certainly in the pump head as well, which led to damage to the bearing, an increase in power consumption, and the pump head noises.The complaint sample was received on august 3, 2026.The investigation confirmed damage to the pump head.The circuit itself showed no leaks or other deficiencies during functional testing.The failure mechanism could be reproduced during testing by tilting the priming bag in a manner that allowed air to enter the venous line and subsequently accumulate in the pump head.The console log data are consistent with sudden decrease in flow caused by air entry into the venous line and the pump head, which likely occurred during transportation of the system.It is very likely that the pump head damage was due to operation with air accumulated in the pump head rather than an inherent defect of the ecmo circuit.The observed failure could be reproduced under this condition, while no additional circuit deficiencies were identified in the returned sample.

• 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: 25592786
• Report Number: 3012172416-2026-00052
• Device Sequence Number: 5700842
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2026
• Device Catalogue Number: 32000014
• Device Lot Number: GSXI0803
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• 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: 09/09/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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).; Novalung Console (Linux Board).
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR
• Patient Sex: Male