XLUNG KIT 230
Received Feb 5, 2025 · Event occurred Jan 20, 2025
Report 3012172416-2025-00014 · MDR key 21311777
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXI0904
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
Description of Event or Problem
A USER FACILITY REPORTED A LEAKAGE AT THE HOUSING COVER OF THE OXYGENATOR DURING PRIMING. UPON FOLLOW-UP, IT WAS REPORTED THE LEAK ORIGINATED ABOVE THE TEMPERATURE SENSOR CONNECTION. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AND RETURNED TO XENIOS ON 31/JAN/2025. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4 PLANT INVESTIGATION: THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE AND/OR ON THE LABEL. DOCUMENTATION OF MODULE PRODUCTION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED FOR THIS BATCH NUMBER. A CRACK WAS FOUND IN THE RECIRCULATION PORT OF THE OXYGENATOR. NO DEFECT WAS OBSERVED AT THE LUER-LOCK ADAPTER (CAVITY NUMBER OF THE INJECTION MOLD IS 4). NO FURTHER INVESTIGATION OF THE COMPLAINT SAMPLE WAS REQUIRED. THE ISSUE WILL CONTINUE TO BE MONITORED.
Description of Event or Problem
A USER FACILITY REPORTED A LEAKAGE AT THE HOUSING COVER OF THE OXYGENATOR DURING PRIMING. UPON FOLLOW-UP, IT WAS REPORTED THE LEAK ORIGINATED ABOVE THE TEMPERATURE SENSOR CONNECTION. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AND RETURNED TO XENIOS ON 31/JAN/2025. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.