XLUNG KIT 230
Received Jun 17, 2025 · Event occurred Jun 3, 2025
Report 3012172416-2025-00055 · MDR key 22225641
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXK2802
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Communication or Transmission Problem
- Output Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- Communication or Transmission Problem
- 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
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 WHILE PRIMING AN XLUNG KIT 230, THE USER COULD NOT GET THE P2 PRESSURE CALIBRATED. IT WAS ALSO TRIED WITH ANOTHER PRESSURE CABLE WITHOUT RESOLUTION AND THE PRESSURE REMAINED AT 390 MMHG. THE FACILITY HAS KEPT THE SYSTEM INCLUDING THE BOX SO XENIOS CAN EVALUATE THE PRODUCT, AS IT REALLY SEEMS TO BE THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem
A USER FACILITY REPORTED THAT WHILE PRIMING AN XLUNG KIT 230, THE USER COULD NOT GET THE P2 PRESSURE CALIBRATED. IT WAS ALSO TRIED WITH ANOTHER PRESSURE CABLE WITHOUT RESOLUTION AND THE PRESSURE REMAINED AT 390 MMHG. THE FACILITY HAS KEPT THE SYSTEM INCLUDING THE BOX SO XENIOS CAN EVALUATE THE PRODUCT, AS IT REALLY SEEMS TO BE THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RETURNED FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D3, G1. PLANT INVESTIGATION: IT WAS REPORTED THAT THE INTEGRATED PRESSURE SENSOR (IPS) P2 COULD NOT BE CALIBRATED. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED FOR THIS BATCH NUMBER AND A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NONCONFORMITY DURING THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE WAS RECEIVED ON JUNE 17, 2025. DURING FUNCTIONAL TESTING OF THE SENSOR, IT WAS NOTICED THAT THE IPS P2 SHOWED A VALUE OF 324 MMHG AND CALIBRATION OF THIS SENSOR COULD NOT BE PERFORMED. IT WAS FOUND THAT THE GEL PAD OF THE PORT WAS NOT IN PLACE AT THE SENSOR WHILE SENSOR AND ELECTRICAL COMPONENTS WERE FOUND DAMAGED. THE SENSOR WAS LIKELY DAMAGED DURING THE MOLDING PROCESS OF THE SENSOR CASING. MEASURES IN MANUFACTURING WERE IMPLEMENTED TO AVOID THIS ERROR IN THE FUTURE.
Description of Event or Problem
A USER FACILITY REPORTED THAT WHILE PRIMING AN XLUNG KIT 230, THE USER COULD NOT GET THE P2 PRESSURE CALIBRATED. IT WAS ALSO TRIED WITH ANOTHER PRESSURE CABLE WITHOUT RESOLUTION AND THE PRESSURE REMAINED AT 390 MMHG. THE FACILITY HAS KEPT THE SYSTEM INCLUDING THE BOX SO XENIOS CAN EVALUATE THE PRODUCT, AS IT REALLY SEEMS TO BE THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RETURNED FOR PRODUCT EVALUATION.