XLUNG KIT 230
Received May 8, 2026 · Event occurred Apr 17, 2026
Report 3012172416-2026-00036 · MDR key 25122318
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXH2504
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- 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 THAT DURING THE CALIBRATION OF THE P1 PRESSURE SENSING PORT, IT WAS FOUND TO BE NOT MEASURABLE. HOWEVER, THE CONSOLE INDICATED THAT ALL PRESSURE MEASUREMENT CABLES WERE OPERATIONAL AT THE SENSOR BOX. THE PRESSURE TRANSDUCERS WERE REPLACED. THE ISSUE PERSISTED AND THE P1 PRESSURE SENSING PORT REMAINED NOT MEASURABLE. THE USER EXCHANGED THE XLUNG KIT 230, ALL PRESSURES COULD BE MEASURED, AND THE SYSTEM COULD BE CALIBRATED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.