XLUNG KIT 230
Received Feb 27, 2026 · Event occurred Feb 11, 2026
Report 3012172416-2026-00018 · MDR key 24469229
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
F32000004
Lot number
FSXI0904
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- Insufficient Device Problem Information
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
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 SHORTLY AFTER STARTING A SECOND XLUNG KIT FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE PATIENT¿S ARTERIAL OXYGENATION (PAO2) WAS 67.5 MMHG. FOLLOWING 90 MINUTES OF SUPPORT, IT DECREASED TO 58.9 MMHG. THE PATIENT WAS SWITCHED TO COMPETITOR PRODUCT. THE PATIENT HAD INFLUENZA AND MRSA. THE OXYGENATOR WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, H3, H4 PLANT INVESTIGATION: NO NON-CONFORMITY WAS OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON MARCH 4, 2026. THE OXYGENATOR HAD BEEN RINSED PRIOR TO SHIPPING, AND THERE WERE NO VISIBLE BLOOD RESIDUES IN THE OXYGENATOR. NO VISIBLE EXTERNAL DEFECTS WERE DETECTED. TESTING OF THE GAS EXCHANGE PERFORMANCE SHOWED THAT THE OXYGEN TRANSFER RATE WAS 38 ML/MIN (LIMIT: 36 ML/MIN). AND THE MEASURED TRANSFER RATE FOR CARBON DIOXIDE WAS 114 ML/MIN (LIMIT 111 ML/MIN). IT WAS DETERMINED THAT THE MEASURED GAS EXCHANGE PERFORMANCE MET THE ACCEPTANCE CRITERIA. AS THE OXYGENATOR PASSED PERFORMANCE TESTING, A DEFINITIVE CAUSE FOR THE REPORTED LOW OXYGEN LEVELS COULD NOT BE DETERMINED.
Description of Event or Problem
A USER FACILITY REPORTED THAT SHORTLY AFTER STARTING A SECOND XLUNG KIT FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE PATIENT¿S ARTERIAL OXYGENATION (PAO2) WAS 67.5 MMHG. FOLLOWING 90 MINUTES OF SUPPORT, IT DECREASED TO 58.9 MMHG. THE PATIENT WAS SWITCHED TO COMPETITOR PRODUCT. THE PATIENT HAD INFLUENZA AND MRSA. THE OXYGENATOR WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY.
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 SHORTLY AFTER STARTING A SECOND XLUNG KIT FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE PATIENT¿S ARTERIAL OXYGENATION (PAO2) WAS 67.5 MMHG. FOLLOWING 90 MINUTES OF SUPPORT, IT DECREASED TO 58.9 MMHG. THE PATIENT WAS SWITCHED TO COMPETITOR PRODUCT. THE PATIENT HAD INFLUENZA AND MRSA. THE OXYGENATOR WAS AVAILABLE FOR PRODUCT EVALUATION. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY.