XLUNG KIT 230
Received Apr 18, 2025 · Event occurred Mar 31, 2025
Report 3012172416-2025-00034 · MDR key 21864002
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXE0603
Product problems
- Leak/Splash
- Mechanical Jam
- Leak/Splash
- Mechanical Jam
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: B5, D4 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. TREND ANALYSIS OF THIS BATCH SHOWED SIMILAR FAILURE PATTERNS. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE LIKELY 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. THE COMPLAINT WAS ASSIGNED TO AN EXISTING CAPA THAT WAS INITIATED AS A RESULT OF SIMILAR FAILURE PATTERNS.
Description of Event or Problem
A USER FACILITY REPORTED, DURING A LEAKAGE TESTING PROCEDURE XENIOS PUBLISHED DURING THE LATEST FIELD SAFETY NOTE, THEY NOTICED A LEAK AT THE RECIRCULATION PORT OF THE OXYGENATOR. THE CUSTOMER HAD ONE OTHER KIT FROM THE COMPLAINT BATCH (B)(4) AND HAS USED IT WITHOUT ISSUES BEFORE THE FIELD SERVICE NOTIFICATION WAS PUBLISHED. A NEW KIT WAS PRIMED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR 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, DURING A LEAKAGE TESTING PROCEDURE XENIOS PUBLISHED DURING THE LATEST FIELD SAFETY NOTE, THEY NOTICED A LEAK AT THE RECIRCULATION PORT OF THE OXYGENATOR. THE CUSTOMER HAD ONE OTHER KIT FROM THE COMPLAINT BATCH (FSXE0603) AND HAS USED IT WITHOUT ISSUES BEFORE THE FIELD SERVICE NOTIFICATION WAS PUBLISHED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION.