XLUNG KIT 230
Received Feb 5, 2026 · Event occurred Jan 21, 2026
Report 3012172416-2026-00005 · MDR key 24267123
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXD2211
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 IN (B)(6) REPORTED A LEAKAGE ON ARTERIAL SIDE OF THE OXYGENATOR OF THE XLUNG KIT 230 DURING PRIMING. THE LEAK WAS NOTED AT THE ARTERIAL SIDE OF THE OXYGENATOR THAT INVOLVED THE CONNECTION BETWEEN THE ARTERIAL DE-AIRING PORT AND THE CIRCUIT TUBING. UPON FOLLOW-UP, IT WAS REPORTED THAT A CRACK WAS FOUND ON THE RECIRCULATION PORT OF THE OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.
Description of Event or Problem
A USER FACILITY IN WIESBADEN REPORTED A LEAKAGE ON ARTERIAL SIDE OF THE OXYGENATOR OF THE XLUNG KIT 230 DURING PRIMING. THE LEAK WAS NOTED AT THE ARTERIAL SIDE OF THE OXYGENATOR THAT INVOLVED THE CONNECTION BETWEEN THE ARTERIAL DE-AIRING PORT AND THE CIRCUIT TUBING. UPON FOLLOW-UP, IT WAS REPORTED THAT A CRACK WAS FOUND ON THE RECIRCULATION PORT OF THE OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, H3 PLANT INVESTIGATION: NO NON-CONFORMITY WAS OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINT HAS BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON JANUARY 29, 2026. A LIQUID LEAK WAS AT THE RECIRCULATION PORT OF THE OXYGENATOR WAS CONFIRMED. A CRACK IN THE RECIRCULATION PORT CAUSED THE LIQUID LEAK. A DEFINITE CAUSE FOR THE CRACK COULD NOT BE IDENTIFIED. THE CONNECTION WAS PROBABLY TIGHTENED WITH TOOLS, PRESUMABLY TO FIX THE LEAK. PREVIOUS INVESTIGATIONS SHOWED THAT CONTRIBUTING FACTORS FOR CRACKS IN THE PORT MIGHT BE TIGHTENING OF THE CAP DURING MANUFACTURING OR INADEQUATE MATERIAL OF THE CAPS.