XLUNG KIT (USA)
Received Jun 12, 2026 · Event occurred May 29, 2026
Report 3012172416-2026-00049 · MDR key 25484664
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F32000004
Lot number
HSXA1906
Product problems
- Leak/Splash
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT THEY DISCOVERED A CRACKED PIGTAIL/STOPCOCK ON THE XLUNG KIT (USA) POST-MEMBRANE PIGTAIL DURING PRIMING OF STERILE CIRCUIT. WHEN PERFORMING THE WET PRIME OF A XLUNG CIRCUIT, A LEAK WAS DISCOVERED AT THE POST-MEMBRANE PIGTAIL. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.