XLUNG KIT 230
Received Jul 25, 2025 · Event occurred Jul 11, 2025
Report 3012172416-2025-00074 · MDR key 22608011
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXL2502
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 THAT AN XLUNG KIT 230 WAS SETUP FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT AND THE PERFUSIONIST NOTICED IT HAD BEEN LEAKING. THE KIT WAS NOT WET, BUT IT WAS VERY CLEAR THAT VISIBLE SALINE SPOTS WERE ON THE TEMPERATURE PROBE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING MANUFACTURING PROCESS. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON OCTOBER 1ST, 2025. IT WAS REPORTED THAT A LEAK OCCURRED AT THE RECIRCULATION PORT. NO DEFECT WAS FOUND AT THE PORT OR THE LUER-LOCK ADAPTER. THE LINE AT THE RECIRCULATION PORT WAS REPLACED WITH A LUER-LOCK CAP AND NO LEAK OCCURRED DURING THE LEAKAGE TEST AT ONE BAR FOR ABOUT AN HOUR. THE ORIGINAL LINE WAS ATTACHED AGAIN AND TIGHTENED. THE LEAK COULD NOT BE REPRODUCED. NO LEAK WAS DETECTED DURING TESTING AT A PRESSURE OF ONE BAR FOR ONE HOUR.
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 THAT AN XLUNG KIT 230 WAS SETUP FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT AND THE PERFUSIONIST NOTICED IT HAD BEEN LEAKING. THE KIT WAS NOT WET, BUT IT WAS VERY CLEAR THAT VISIBLE SALINE SPOTS WERE ON THE TEMPERATURE PROBE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.