XLUNG KIT 230
Received Oct 7, 2025 · Event occurred Sep 19, 2025
Report 3012172416-2025-00099 · MDR key 23232260
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXB1704
Product problems
- Device Misassembled During Manufacturing /Shipping
- Manufacturing, Packaging or Shipping Problem
- Component Misassembled
- Device Misassembled During Manufacturing /Shipping
- Manufacturing, Packaging or Shipping Problem
- Component Misassembled
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THE ONE-WAY VALVE IN THE TUBING OF THE XLUNG KIT 230 WAS INCORRECTLY SET IN THE CIRCUIT AND DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
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 THE ONE-WAY VALVE IN THE TUBING OF THE XLUNG KIT 230 WAS INCORRECTLY SET IN THE CIRCUIT AND DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5 PLANT INVESTIGATION: NO OTHER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION ON (B)(6) 2025. IT WAS FOUND THAT THE ONE-WAY VALVE WAS FITTED UPSIDE DOWN IN THE LINE OF THE PRIMING SET BY MANUFACTURING. THE SAMPLE WAS EXAMINED, AND THE ERROR WAS CONFIRMED. AS THIS WAS A PRODUCTION ERROR, THE EMPLOYEES COMPLETED ADDITIONAL TRAINING TO AVOID FUTURE OCCURRENCE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9 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 THE ONE-WAY VALVE IN THE TUBING OF THE XLUNG KIT 230 WAS INCORRECTLY SET IN THE CIRCUIT AND DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.