MalfunctionQJZ
XLUNG KIT 230
Received Jun 2, 2026 · Event occurred Feb 8, 2026
Report 3012172416-2026-00044 · MDR key 25359134
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXE1305
Product problems
- Leak/Splash
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED A LEAKAGE OCCURRED FROM THE VENTING PORT DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.