XLUNG KIT 230
Received Jan 30, 2026 · Event occurred Nov 20, 2025
Report 3012172416-2026-00003 · MDR key 24225349
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXA0602
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
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 THE PUMP HEAD OF THE XLUNG KIT 230 WAS MAKING NOISES, AND THE PROPELLER WAS SPINNING ABNORMALLY DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE PUMP HEAD COMPONENT OF THE KIT WAS AVAILABLE FOR PRODUCT INVESTIGATION AND RECEIVED BY XENIOS.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION. UPON PRODUCT INVESTIGATION, IT WAS DETERMINED THAT THE CERAMIC BALL THAT STABILIZES THE ROTOR HAD MELTED. THE MOST PROBABLE ROOT CAUSE FOR THE MELTED CERAMIC BALL COULD BE REMAINING AIR IN THE ROTOR AREA DUE TO INADEQUATE PRIMING OF THE CIRCUIT BY THE USER. THE COMPLAINT WAS RECORDED STATISTICALLY. IF MONITORING REVEALS AN ADVERSE TREND, FURTHER INVESTIGATION WILL BE CARRIED OUT.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE PUMP HEAD OF THE XLUNG KIT 230 WAS MAKING NOISES, AND THE PROPELLER WAS SPINNING ABNORMALLY DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE PUMP HEAD COMPONENT OF THE KIT WAS AVAILABLE FOR PRODUCT INVESTIGATION AND RECEIVED BY XENIOS.