XLUNG KIT 230
Received May 9, 2025 · Event occurred Apr 23, 2025
Report 3012172416-2025-00044 · MDR key 21994787
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXD0810
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
ADDITIONAL INFORMATION: D3, D4, G1. PLANT INVESTIGATION: A PRODUCTION BATCH REVIEW REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS RELATED TO THE OBSERVED FAILURE. SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH THAT DESCRIBE LEAKS AT THE RECIRCULATION PORT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE CAUSE OF A POSSIBLE LEAK AT THIS LOCATION HAS BEEN IDENTIFIED. IT WAS FOUND THAT THERE WAS A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT THAT RESULTED IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. THIS DEVIATION HAS SINCE BEEN CORRECTED.
Description of Event or Problem
A USER FACILITY REPORTED A LEAKAGE IN THE OXYGENATOR RECIRCULATION PORT THAT WAS OBSERVED DURING PRIMING OF THE XLUNG KIT 230. THE CIRCUIT WAS NOT USED AND QUARANTINED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT 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 LEAKAGE IN THE OXYGENATOR RECIRCULATION PORT THAT WAS OBSERVED DURING PRIMING OF THE XLUNG KIT 230. THE CIRCUIT WAS NOT USED AND QUARANTINED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.