XLUNG KIT 230
Received Aug 28, 2025 · Event occurred Aug 8, 2025
Report 3012172416-2025-00088 · MDR key 22911180
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXI0201
Product problems
- Crack
- Leak/Splash
- Material Integrity Problem
- Crack
- Leak/Splash
- Material Integrity 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
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 A VENTING PORT OF XLUNG KIT 230 WAS DAMAGED. THE BREAKAGE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9, H3. PLANT INVESTIGATION: MANUFACTURING DOCUMENTATION SHOWED NO DEVIATIONS CONCERNING THE FAILURE PATTERN AT HAND. NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON AUGUST 29, 2025. THE SAMPLE ARRIVED WITH LIQUID RESIDUES IN THE OXYGENATOR. THE BROKEN VENTING PORT AT THE TOP OF THE OXYGENATOR WAS BROKEN AT THE 90-DEGREE ANGLE. NO FURTHER DAMAGE WAS NOTED TO THE KIT OR THE PACKAGING. THE PROBABLE CAUSE FOR THE DAMAGED OXYGENATOR IS THAT IT WAS NOT CORRECTLY SECURED INSIGHT THE PACKAGING AND THE PORT BROKE DURING TRANSPORT.
Description of Event or Problem
A USER FACILITY REPORTED THAT A VENTING PORT OF XLUNG KIT 230 WAS DAMAGED. THE BREAKAGE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.