MalfunctionQJZ
XLUNG Kit 230
Received Jun 26, 2026 · Event occurred Jun 9, 2026
Report 3012172416-2026-00057 · MDR key 25633615
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXH0418
Product problems
- Fluid/Blood Leak
- Leak/Splash
- Mechanical Problem
Patient
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 REPORTED THE RECIRCULATION PORT OF THE XLUNG KIT 230 HAD A LEAKAGE FOLLOWING A FEW MINUTES OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT START. THE PHYSICIAN EXCHANGED THE KIT. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50 ML AS A RESULT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.