XLUNG KIT 230
Received Sep 12, 2025 · Event occurred Aug 29, 2025
Report 3012172416-2025-00096 · MDR key 23037782
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXD2216
Product problems
- Leak/Splash
- Mechanical Problem
- Leak/Splash
- Mechanical Problem
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- 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 THEY OBSERVED A LEAK AT THE RECIRCULATION PORT OF THE XLUNG KIT 230 OXYGENATOR DURING PRIMING. THE RELATED FSN WAS SUBMITTED TO THE FACILITY AND RECEIPT WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4 PLANT INVESTIGATION: THREE SIMILAR COMPLAINTS HAVE BEEN REPORTED CONCERNING THIS BATCH NUMBER, AND A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO NON-CONFORMITY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A PHOTO PROVIDED SHOWS A LEAK AT THE RECIRCULATION PORT. THE CAUSE OF THE LEAK IS A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT WHICH RESULTS IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK.
Description of Event or Problem
A USER FACILITY REPORTED THAT THEY OBSERVED A LEAK AT THE RECIRCULATION PORT OF THE XLUNG KIT 230 OXYGENATOR DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.