MAUDE Adverse Event Report: XENIOS AG NOVALUNG CONSOLE (LINUX BOARD); EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE

Catalog Number	F30000162
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/05/2024
Type of Reportable Event	Death
Event or Problem Description
A user facility reported that a patient came to the cardiac catheterization lab for a ventricular tachycardia and ventricular ectopic arrest for initiation of extracorporeal cardiopulmonary resuscitation.The novalung device was prepped to hand up the patient circuit into the sterile field to start support.When handed up to the sterile field, the p2 pressure cable broke and was not detected on the console screen.An attempt was made to pull the cord and switch to another cable; however, the cable was stuck in the device.Within a few minutes of ecmo support the p3 pressure cable also was not reading a pressure, and it was found to be in the xlung kit, but not able to read a pressure.This cable also remained in the device.Ecmo support was not stopped due to the urgency of support at that time.The patient was hooked up to blood pressure and ekg monitors to ensure best care practices were followed.Also, the novalung console was reading a total flow to patient with rpms.The facility¿s best practice is to initiate ecmo with fio2 of 50%.There was no color change that was noted on arterial limb of circuit until the oxygen level was increased to maximum support of 100% oxygen.Upon arrival to the icu, the patient pressure cables were switched, and once changed, the clinicians were able to note the negative pressure (p1) was -400 mmhg.The accepted normal is less than -100 mmhg and ideally around -50 mmhg.The other astounding thing was the ecmo circuit did not "chug" to indicate it was indeed dry or needed more fluid from the patient.Ultimately, the patient expired within 5 hours of arrival.The disposable was sent back to fresenius due to the oxygenator not functioning.Arterial blood gases were drawn on the post-oxygenator side with an fio2 of 100% and the highest yield was an arterial oxygen of 87 mmhg.An arterial oxygen directly from the patient was 89 mmhg which indicated the patient's lungs were doing the work as it was higher than the device.

• Brand Name: NOVALUNG CONSOLE (LINUX BOARD)
• 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
• MDR Report Key: 24965509
• Report Number: 3012417381-2026-00003
• Device Sequence Number: 10455436
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/23/2026
• Report Date (Section F): 04/23/2026

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: F30000162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2025
• Device Age: MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XLUNG KIT (USA)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/23/2026