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

Model Number	XLUNG KIT (USA)
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2026
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 the p3 integrated sensor was not working on the xlung kit (usa) circuit.The sensor did not light up green on the console during priming and read no pressure during extracorporeal membrane oxygenation (ecmo) support.The ecmo specialist had no time to change anything as cannulation occurred within 7 minutes.The user added an external pressure sensor to p3 and the circuit was still in use on the patient.There was no patient serious injury.The complaint sample is anticipated for product evaluation once discontinued from patient support.
Additional Manufacturer Narrative
Additional information: b5, d9, h3.Plant investigation: the sample was not available for evaluation.No retention sample analysis was performed since the lot of the product was unknown.10 similar complaints have been reported in 24 months.As no further information was provided concerning the complaint sample, no findings were available and a cause of this event could not be established.
Event or Problem Description
A user facility reported that the p3 integrated sensor was not working on the xlung kit (usa) circuit.The sensor did not light up green on the console during priming and read no pressure during extracorporeal membrane oxygenation (ecmo) support.The ecmo specialist had no time to change anything as cannulation occurred within 7 minutes.The user added an external pressure sensor to p3 and the circuit was still in use on the patient.There was no patient serious injury.The complaint sample was discarded onsite and unavailable 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
• 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: 24468750
• Report Number: 3012172416-2026-00016
• Device Sequence Number: 15848253
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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 Model Number: XLUNG KIT (USA)
• Device Catalogue Number: F32000004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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).
• Patient Sex: Unknown