XLUNG KIT 230
Received Sep 4, 2025 · Event occurred Aug 17, 2025
Report 3012172416-2025-00090 · MDR key 22961981
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXF1013
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Male
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- 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 FROM WIESBADEN REPORTED LOW POST-OXYGENATOR OXYGEN. THERE WAS A DESCRIBED "POWER LOSS" FROM THE OXYGENATOR IN THE XLUNG KIT 230. THE POST-OXYGENATOR ARTERIAL BLOOD GAS WAS CHECKED IMMEDIATELY AFTER PRIMING AND CONNECTION TO THE PATIENT WHICH WAS NOTICEABLE [FOR LOW OXYGEN]. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9. H3, H6 PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS OF BATCH FSXF1013. THREE OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE OXYGENATOR WAS RECEIVED ON NOVEMBER 12, 2025. THE SAMPLE ARRIVED WITH BLOOD RESIDUES IN THE OXYGENATOR. NO VISIBLE EXTERNAL DEFECTS WERE FOUND. MOST OF THE REMAINING BLOOD RESIDUE COULD BE REMOVED BY FLUSHING. HOWEVER, IN SOME AREAS OF THE GAS EXCHANGE MEMBRANE AND IN THE HEAT EXCHANGER OF THE OXYGENATOR COAGULATED BLOOD WAS STILL VISIBLE. THE PERFORMANCE TEST SHOWED THAT THE OXYGENATOR´S OXYGEN TRANSFER RATE WAS WITHIN SPECIFICATION. PRESSURE MEASUREMENT SHOWED AN ELEVATED DELTA P (PRESSURE DIFFERENCE BETWEEN PRE-OXYGENATOR AND POST-OXYGENATOR) OF 93 MMHG AT 3 L/MIN, INDICATING AN OBSTRUCTION IN THE OXYGENATOR. IT IS UNKNOWN WHEN OR HOW THIS OBSTRUCTION DEVELOPED, OR WHETHER IT WAS DURING OR AFTER TERMINATION OF SUPPORT; HOWEVER, IT MAY CONTRIBUTE TO LOWER-THAN-EXPECTED POST-OXYGENATOR ARTERIAL OXYGEN. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES.
Description of Event or Problem
A USER FACILITY FROM WIESBADEN REPORTED LOW POST-OXYGENATOR OXYGEN. THERE WAS A DESCRIBED "POWER LOSS" FROM THE OXYGENATOR IN THE XLUNG KIT 230. THE POST-OXYGENATOR ARTERIAL BLOOD GAS WAS CHECKED IMMEDIATELY AFTER PRIMING AND CONNECTION TO THE PATIENT WHICH WAS NOTICEABLE [FOR LOW OXYGEN]. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.