XLUNG KIT 230
Received Apr 30, 2025 · Event occurred Apr 15, 2025
Report 3012172416-2025-00039 · MDR key 21935331
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
UNKNOWN
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
Description of Event or Problem
A USER FACILITY REPORTED THAT AFTER PRIMING THE XLUNG KIT 230, THE USER NOTICED A SALINE LEAK AT THE RECIRCULATION PORT OF THE OXYGENATOR. AN ADDITIONAL KIT WAS PRIMED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5. PLANT INVESTIGATION: SIMILAR COMPLAINTS THROUGH TREND ANALYSIS HAVE BEEN REPORTED REGARDING LEAKS FROM THE RECIRCULATION PORT. BASED ON THE DESCRIPTION, THE COMPLAINT WAS ASSIGNED TO AN EXISTING CAPA AS IT WAS ASSUMED THAT THE LEAK WAS CAUSED BY MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT. HOWEVER, NO FURTHER INVESTIGATION COULD BE CARRIED OUT, AS THE BATCH NUMBER OF THE PRODUCT IS UNKNOWN AND THE XLUNG KIT 230 WAS DISCARDED. THE SUSPECTED CAUSE INVOLVED A KNOWN MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT, RESULTING IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. THIS DEVIATION HAS SINCE BEEN CORRECTED.
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 AFTER PRIMING THE XLUNG KIT 230, THE USER NOTICED A SALINE LEAK AT THE RECIRCULATION PORT OF THE OXYGENATOR. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.