MalfunctionQJZ
XLUNG KIT 230
Received May 26, 2026 · Event occurred Apr 20, 2026
Report 3012172416-2026-00039 · MDR key 25276649
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXG2114
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 THAT THERE WAS A SMALL CRACK IN THE LUER-LOCK CONNECTOR ON THE OXYGEN CONCENTRATOR HOUSING THAT WAS NEAR THE RED VALVE ON THE ARTERIAL SIDE. THE CRACK CAUSED A PERSISTENT LEAK DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.