XLUNG KIT 230
Received Aug 19, 2025 · Event occurred Jul 31, 2025
Report 3012172416-2025-00081 · MDR key 22838363
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXL0901
Product problems
- Leak/Splash
- Leak/Splash
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
Description of Event or Problem
A USER FACILITY REPORTED A FLUID LEAK DURING PRIMING THE XLUNG KIT 230 FOR EXTRACORPOREAL MEMBRANE OXYGENATION. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
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 FLUID LEAK DURING PRIMING THE XLUNG KIT 230 FOR EXTRACORPOREAL MEMBRANE OXYGENATION. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE LEAK OCCURRED AT THE RECIRCULATION PORT AND A CRACK IN THE PORT WAS DETERMINED TO BE THE CAUSE. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9 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 FLUID LEAK DURING PRIMING THE XLUNG KIT 230 FOR EXTRACORPOREAL MEMBRANE OXYGENATION. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE LEAK OCCURRED AT THE RECIRCULATION PORT AND A CRACK IN THE PORT WAS DETERMINED TO BE THE CAUSE. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION WHERE IT WAS FOUND THAT THERE WAS A CRACK AT THE RECIRCULATION PORT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. TWO OTHER COMPLAINTS HAVE BEEN REPORTED CONCERNING THIS BATCH NUMBER BUT DID NOT FOLLOW THE SAME FAILURE PATTERN. THE DESCRIBED PROBLEM COULD NOT BE REPRODUCED. A LEAK WAS FOUND AT THE RECIRCULATION PORT. FURTHER INSPECTION REVEALED A CRACK IN THE RECIRCULATION PORT.