XLUNG KIT 230
Received Apr 14, 2026 · Event occurred Mar 31, 2026
Report 3012172416-2026-00029 · MDR key 24870481
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
UNKNOWN
Product problems
- 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 AFTER ANOTHER XLUNG KIT 230 WAS UTILIZED FOR APPROXIMATELY 10 DAYS WITHOUT ISSUE. THE USER ROUTINELY CHANGED THE PATIENT KIT TO ANOTHER XLUNG KIT 230. THE PATIENT'S FIRST POST OXYGENATOR ARTERIAL OXYGEN WAS AT APPROXIMATELY 150 MMHG AND QUICKLY DECREASED TO 100 MMHG WHILE THE ARTERIAL SATURATION OF OXYGEN OF THE PATIENT REMAINED AT 70%. THE PATIENT WAS TRANSITIONED TO A CARDIOHELP SYSTEM AND ACCORDING TO THE USER SHOWED SUFFICIENT GAS EXCHANGE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D9 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 AFTER ANOTHER XLUNG KIT 230 WAS UTILIZED FOR APPROXIMATELY 10 DAYS WITHOUT ISSUE. THE USER ROUTINELY CHANGED THE PATIENT KIT TO ANOTHER XLUNG KIT 230. THE PATIENT'S FIRST POST OXYGENATOR ARTERIAL OXYGEN WAS AT APPROXIMATELY 150 MMHG AND QUICKLY DECREASED TO 100 MMHG WHILE THE ARTERIAL SATURATION OF OXYGEN OF THE PATIENT REMAINED AT 70%. THE PATIENT WAS TRANSITIONED TO A CARDIOHELP SYSTEM AND ACCORDING TO THE USER SHOWED SUFFICIENT GAS EXCHANGE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED BY THE MANUFACTURER FOR PRODUCT INVESTIGATION.