XLUNG KIT 230
Received Jun 8, 2026 · Event occurred May 22, 2026
Report 3012172416-2026-00045 · MDR key 25426697
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXB2401
Product problems
- Leak/Splash
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED AN OXYGENATOR LEAK THAT WAS DETECTED ON THE NOVALUNG XLUNG KIT 230 (REF: 32000014, LOT: GSXB2401) DURING PRIMING AT NUH - MOT. PRIMING WAS STOPPED IMMEDIATELY. THE DEFECTIVE KIT WAS REPLACED WITH A NEW UNIT. THE DEFECTIVE KIT SET ASIDE FOR COMPLAINT PROCESSING AND RETURN TO 3PL FOR QUARANTINE PENDING INVESTIGATION. NO PATIENT WAS CONNECTED AT THE TIME OF THE INCIDENT. THE DEFECTIVE KIT WAS IDENTIFIED PRIOR TO PATIENT USE. VIDEOGRAPHIC EVIDENCE SHOWED A SLOW LEAK FROM THE POST-OXYGENATOR SAMPLING PORT.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.