XLUNG KIT 230
Received Aug 22, 2025 · Event occurred Aug 6, 2025
Report 3012172416-2025-00083 · MDR key 22871271
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXA0602
Product problems
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
- Fluid/Blood Leak
- 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 THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED A BLOOD LEAK AT THE TOP OF THE XLUNG KIT 230 OXYGENATOR'S ARTERIAL SIDE. THE KIT WAS EXCHANGED AND NO HARM CAME TO THE PATIENT. THERE WAS NO LEAK NOTICED DURING PRIMING. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED A BLOOD LEAK AT THE TOP OF THE XLUNG KIT 230 OXYGENATOR'S ARTERIAL SIDE. THE KIT WAS EXCHANGED AND NO HARM CAME TO THE PATIENT. THERE WAS NO LEAK NOTICED DURING PRIMING. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION; HOWEVER, THE PRODUCT WAS NOT RETURNED FROM THE USER FACILITY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9, H3. PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING MANUFACTURING PROCESS. NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AND A CAUSE FOR THE LEAK AND/OR THE CRACK COULD NOT BE CONFIRMED. A PHOTO HAS BEEN PROVIDED SHOWING A BLOOD LEAK THAT IS COMING FROM THE RECIRCULATION PORT. DUE TO 100% TESTING, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. 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.