XLUNG KIT 230
Received Jun 23, 2026 · Event occurred Jun 1, 2026
Report 3012172416-2026-00053 · MDR key 25592888
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXI0103
Product problems
- Leak/Splash
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 REPORTED THAT ON THE MORNING OF (B)(6) 2026, A SIGNIFICANT PUDDLE WAS OBSERVED AT THE BASE OF THE MACHINE, AND THE XLUNG KIT TRAY WAS FILLED WITH FLUID. THE EXACT SOURCE OF THE LEAK COULD NOT BE IDENTIFIED; HOWEVER, UPON OPENING THE TRAY, ONE OF THE TUBES CONNECTED TO THE 3/8" FITTING APPEARED TO BE INSUFFICIENTLY INSERTED. IT SHOULD BE NOTED THAT AS THE CIRCUIT WAS FULL OF AIR THE PUMP HEAD WAS DAMAGED DURING OPERATION. THE CIRCUIT THEREFORE HAD TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.