XLUNG KIT 230
Received Nov 4, 2025 · Event occurred Oct 20, 2025
Report 3012172416-2025-00107 · MDR key 23464455
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXC1009
Product problems
- Leak/Splash
- Mechanical Problem
- Leak/Splash
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED A LEAKAGE DURING PREPARATION OF THE XLUNG KIT 230 FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, H3. PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING MANUFACTURING PROCESS. NO SIMILAR COMPLAINTS CONCERNING THIS BATCH NUMBER HAVE BEEN REPORTED. ALL OXYGENATORS ARE TESTED FOR LEAKAGES DURING PROCESS CONTROLS. THE CRACK MAY HAVE BEEN SUBSEQUENTLY CAUSED BY THE RELEASE OF MATERIAL STRESS, FOR EXAMPLE DURING HANDLING, E.G. TIGHTENING OF THE CONNECTION OR TRANSPORT. POTENTIAL ROOT CAUSES DURING PRODUCTION HAVE BEEN ANALYZED, AND MEASURES ARE BEING IMPLEMENTED.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A USER FACILITY REPORTED A LEAKAGE DURING PREPARATION OF THE XLUNG KIT 230 FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.