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	Display or Visual Feedback Problem (1184); Output Problem (3005); Insufficient Device Problem Information (3190); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
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 for several months now, perfusionists at (b)(6) hospital in (b)(6) have been reporting about a backflow detection problems on the novalung console, serial (b)(6).This incident causes the pump to accelerate to compensate for a false backflow detected on the console.The country complaint administrator retrieved the machine log files confirming the problem.There was no indication of patient serious injury.The complaint sample was available for product investigation.
Event or Problem Description
A user facility reported that for several months now, perfusionists at (b)(6) hospital in (b)(6) have been reporting about a backflow detection problems on the novalung console, serial (b)(6).This incident causes the pump to accelerate to 10,000 rpm to compensate for a false backflow detected on the console.The country complaint administrator retrieved the machine log files confirming the problem.Upon follow-up, it was reported this event occurred one to two times during support but was not a systematic issue.Associated console alarms included #114 (backflow detected - zero flow activated) and # 221 (blood flow too low).An exchange of the flow sensor alleviated the issue.It was confirmed that there was no resulting patient serious injury.The complaint sample remains available for product investigation.However, the manufacturer is awaiting receipt of the complaint sample.
Additional Manufacturer Narrative
Additional information: b5.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: b5, d9, h3 plant investigation: non-conformity was not observed during manufacturing process.Final inspection resulted with conformity.Repair history of the console showed no related repairs.The flow sensor was received for evaluation.No external visible damage to the sensor was noted.The sensor was tested on a testing console.No malfunction of the flow measurement could be observed.The flow measurement was compared with another flow sensor connected to a second console.During a test run of approximately 14 hours, no malfunction or deviation of the flow measurement was observed.The machine files showed that the console detected a backflow and issued alarm #114 when a negative flow was measured.The data does not indicate any malfunction of the console.The data showed that after zeroing of the flow sensor, a negative and varying flow was measured while the pump was inactive or at zero rpm.It is possible that the sensor was zeroed while there was still a flow.Reportedly, the issue resolved after the flow sensor was replaced, however, no defect or malfunction could be detected in the flow sensor.
Event or Problem Description
A user facility reported that for several months now, perfusionists at henri mondor hospital in créteil have been reporting about a backflow detection problems on the novalung console, serial (b)(6).This incident causes the pump to accelerate to 10,000 rpm to compensate for a false backflow detected on the console.The country complaint administrator retrieved the machine log files confirming the problem.Upon follow-up, it was reported this event occurred one to two times during support but was not a systematic issue.Associated console alarms included #114 (backflow detected - zero flow activated) and #221 (blood flow too low).An exchange of the flow sensor alleviated the issue.It was confirmed that there was no resulting patient serious injury.The complaint sample was received for product investigation.

• 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
• 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: 22813973
• Report Number: 3012172416-2025-00078
• Device Sequence Number: 8703530
• Product Code: QJZ
• UDI-Device Identifier: 04057224902043
• UDI-Public: 04057224902043
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: F30000162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 12/16/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/04/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: XLUNG KIT 230.; XLUNG KIT 230.; XLUNG KIT 230.
• Patient Sex: Unknown