XLUNG KIT 230
Received Oct 16, 2025 · Event occurred Sep 30, 2025
Report 3012172416-2025-00101 · MDR key 23309000
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXA0602
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
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 LEAK FROM THE VENOUS LUER-LOCK CONNECTION FROM THE XLUNG 230 DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING MANUFACTURING PROCESS. TWO SIMILAR COMPLAINTS ABOUT 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 IMPLEMENTED.
Description of Event or Problem
A USER FACILITY REPORTED A LEAK FROM THE VENOUS LUER-LOCK CONNECTION FROM THE XLUNG 230 DURING PRIMING. THE KIT WAS SEQUESTERED AND AN ADDITIONAL KIT WAS PRIMED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.