XLUNG KIT 230
Received Oct 23, 2025 · Event occurred Oct 6, 2025
Report 3012172416-2025-00103 · MDR key 23366936
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
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 THAT DURING PRIMING OF THE XLUNG KIT 230, THE USER NOTICED A P2 VALUE OF OVER 400 MMHG. ADDITIONALLY, THE USERS WERE NOT ABLE TO CALIBRATE THE P2 PRESSURE READING. THE KIT WAS EXCHANGED AS THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, H6 PLANT INVESTIGATION: NO REVIEW OF THE BATCH DOCUMENTATION COULD BE CARRIED OUT SINCE THE BATCH NUMBER OF THE PRODUCT IS UNKNOWN. IF A PRESSURE VALUE OF OVER 400 MMHG IS MEASURED, IT IS NOT POSSIBLE TO PERFORM A ZERO ADJUSTMENT ON THE CONSOLE. THIS COULD BE CAUSED BY MECHANICAL DAMAGE TO THE ELECTRICAL COMPONENTS OF THE SENSOR OR BY LIQUID ENTERING THE SENSOR. HOWEVER, BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
A USER FACILITY REPORTED THAT DURING PRIMING OF THE XLUNG KIT 230, THE USER NOTICED A P2 VALUE OF OVER 400 MMHG. ADDITIONALLY, THE USERS WERE NOT ABLE TO CALIBRATE THE P2 PRESSURE READING. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.