XLUNG KIT 230
Received Feb 12, 2026 · Event occurred Jan 24, 2026
Report 3012172416-2026-00010 · MDR key 24321673
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXD2213
Product problems
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED A BLOOD LEAK OF APPROXIMATELY 200 ML DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE CIRCUIT WAS EXCHANGED FOLLOWING PATIENT TRANSPORT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
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 BLOOD LEAK OF APPROXIMATELY 200 ML DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE CIRCUIT WAS EXCHANGED FOLLOWING PATIENT TRANSPORT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. SIX SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. PHOTOS WERE PROVIDED THAT SHOWED BLOOD AT THE OUTSIDE OF THE OXYGENATOR, AT THE RECIRCULATION PORT AND BELOW AT THE CARDIOPLEGIA AND TEMPERATURE PORTS. BASED ON THE INFORMATION PROVIDED, IT IS ASSUMED THAT A LEAK OCCURRED AT THE RECIRCULATION PORT. INVESTIGATION OF PREVIOUS COMPLAINTS REVEALED A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT RESULTS IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK.