XLUNG KIT 230
Received Jul 10, 2025 · Event occurred Jun 21, 2025
Report 3012172416-2025-00062 · MDR key 22467890
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXE1305
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 LIQUID LEAKAGE THAT OCCURRED AT THE RECIRCULATION PORT OF THE XLUNG KIT 230 DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, H3 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. TWO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE SAMPLE WAS RECEIVED ON JULY 4, 2025. THE PRODUCT ARRIVED WITH LIQUID RESIDUES IN THE TUBING AND OXYGENATOR. THE TWO VENTING LINES WERE REVERSED ON THE OXYGENATOR: THE RED VENTING LINE WAS CONNECTED TO THE VENOUS VENTING PORT, AND THE BLUE VENTING LINE WAS CONNECTED TO THE RECIRCULATION PORT. SAMPLE INVESTIGATION CONFIRMED A SMALL LEAK COMING FROM THE RECIRCULATION PORT. A LEAK OCCURRED AT THE PORT WITH THE BLUE VENTING LINE ATTACHED. A LEAK OCCURRED AT THE PORT WITH THE RED VENTING LINE ATTACHED AS WELL. NO DEFECT WAS VISIBLE AT THE PORT OR THE LUER-LOCK POSITIVE ADAPTERS OF THE VENTING LINES. THE CAVITY NUMBER OF THE INJECTION MOLD OF THE LUER-LOCK POSITIVE ADAPTER ARE 1 (RED VENTING LINE) AND 7 (BLUE VENTING LINE). 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 A LIQUID LEAKAGE THAT OCCURRED AT THE RECIRCULATION PORT OF THE XLUNG KIT 230 DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE NOTED AT THE LEAK LOCATION. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION BY XENIOS ON 4/JUL/2025.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, G2. 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 LIQUID LEAKAGE THAT OCCURRED AT THE RECIRCULATION PORT OF THE XLUNG KIT 230 DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE NOTED AT THE LEAK LOCATION. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS ON 4/JUL/2025.