XLUNG KIT 230
Received Apr 22, 2025 · Event occurred Mar 29, 2025
Report 3012172416-2025-00035 · MDR key 21880480
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXD1508
Product problems
- Leak/Splash
- Mechanical Problem
- Leak/Splash
- Mechanical Problem
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- 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 A LEAKING OXYGENATOR DURING PRIMING OF THE XLUNG KIT 230. THE USER NOTICED SALINE SOLUTION LEAKING FROM THE TEMPERATURE MEASUREMENT PORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, AND NO PHOTOGRAPHS OF THE LEAK WERE AVAILABLE. AS A RESULT, A DEFINITIVE CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
A USER FACILITY REPORTED A LEAKING OXYGENATOR DURING PRIMING OF THE XLUNG KIT 230. THE USER NOTICED SALINE SOLUTION LEAKING FROM THE TEMPERATURE MEASUREMENT PORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND NOT AVAILABLE FOR PRODUCT EVALUATION.