XLUNG KIT 230
Received Dec 23, 2025 · Event occurred Dec 5, 2025
Report 3012172416-2025-00118 · MDR key 23876554
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXD1511
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE MANUFACTURER REPORTED THAT DURING OPERATION OF THE CONSOLE AT THE BAD HOMBURG OFFICE BY XENIOS APPLICATION SPECIALISTS, THE P3 VALUE WAS NOT DISPLAYED OR RECOGNIZED ON THE CONSOLE UPON CONNECTING THE P3 SENSOR TO THE XLUNG KIT 230. SWITCHING THE INTEGRATED PRESSURE SENSING CONNECTING CABLE DID NOT RESOLVE THE ISSUE. 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
THE MANUFACTURER REPORTED THAT DURING OPERATION OF THE CONSOLE AT THE BAD HOMBURG OFFICE BY XENIOS APPLICATION SPECIALISTS, THE P3 VALUE WAS NOT DISPLAYED OR RECOGNIZED ON THE CONSOLE UPON CONNECTING THE P3 SENSOR TO THE XLUNG KIT 230. SWITCHING THE INTEGRATED PRESSURE SENSING CONNECTING CABLE DID NOT RESOLVE THE ISSUE. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION; HOWEVER, THE DEVICE WAS NOT RETURNED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR PRODUCT EVALUATION. AS THE SAMPLE WAS NOT RETAINED, A DEFINITIVE CAUSE FOR DESCRIBED FAILURE OF THE INTEGRATED PRESSURES SENSING PORT OF THE XLUNG KIT 230 COULD NOT BE DETERMINED.