XLUNG KIT 230
Received Jun 25, 2026 · Event occurred Jun 5, 2026
Report 3012172416-2026-00056 · MDR key 25619698
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXD0111
Product problems
- Obstruction of Flow
Patient
NA · Unknown
- 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 SUSPECTED THAT THERE WAS AN OBSTRUCTION AT THE RECIRCULATION PORT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE RED SIDE BRANCH TUBING WAS FOUND BLOCKED AT THE START OF SUPPORT. THE KIT WAS EXCHANGED. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50 ML AS A RESULT OF THIS EVENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.