XLUNG KIT 230
Received Sep 11, 2025 · Event occurred Aug 19, 2025
Report 3012172416-2025-00092 · MDR key 23025954
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXL1111
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Defective Component
- Output Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Defective Component
- Output 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
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9, H3 PLANT INVESTIGATION: NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER, AND A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE WAS RECEIVED ON SEPTEMBER 16TH, 2025. IN SUMMARY, IT WAS DETERMINED THAT THE CERAMIC BALL HAD MELTED DUE TO A LACK OF DE-AIRING TECHNIQUE PRIOR TO PRIMING THE SYSTEM. THE MOST PROBABLE ROOT CAUSE FOR MELTED CERAMIC BALL INVOLVE REMAINING AIR IN THE ROTOR AREA. IN ADDITION, EMPLOYEES WILL RECEIVE REFRESHER TRAINING ON THE WORK INSTRUCTION THAT INVOLVES GLUING THE CERAMIC BALL IN THE IMPELLER.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE ROTOR IN THE PUMP HEAD OF THE XLUNG KIT 230 WAS MISALIGNED WHICH CAUSED AN OPERATIONAL FAILURE AFTER INSTALLATION. THE KIT WAS EXCHANGED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE ROTOR IN THE PUMP HEAD OF THE XLUNG KIT 230 WAS MISALIGNED WHICH CAUSED AN OPERATIONAL FAILURE AFTER INSTALLATION. THE KIT WAS EXCHANGED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.