XLUNG KIT 230
Received Dec 30, 2025 · Event occurred Dec 11, 2025
Report 3012172416-2025-00119 · MDR key 23920729
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSHE0517
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 · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION, A3, A4, B5, D9 THE PLANT INVESTIGATION IS IN PROCESS. AN ADDITIONAL SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A USER FACILITY REPORTED THAT A PATIENT WITH ACUTE RESPIRATORY DISTRESS SYNDROME AND INFLUENZA PNEUMONIA HAD A POST-OXYGENATOR ARTERIAL OXYGEN OF APPROXIMATELY 100 MMHG WITH 100% FRACTION OF INSPIRED OXYGEN UPON THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE XLUNG KIT WAS EXCHANGED FOR A NEW KIT. THE PATIENT REQUIRED AN ADJUSTMENT ON VENTILATION AS A RESULT OF THIS EVENT. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON DECEMBER 22, 2025. THE OXYGENATOR HAD BEEN RINSED PRIOR TO SHIPPING. NO VISIBLE EXTERNAL DEFECTS WERE DETECTED. SOME RESIDUES OF RINSING FLUID MIXED WITH BLOOD VISIBLE IN THE GAS EXCHANGER. THE PRODUCT WAS RINSED, AND THESE RESIDUES WERE REMOVED. TESTING OF THE GAS EXCHANGE PERFORMANCE SHOWED THAT THE OXYGEN TRANSFER RATE WAS 45 ML/MIN (LIMIT: 36 ML/MIN). AND THE MEASURED TRANSFER RATE FOR CO2 WAS 128 ML/MIN (LIMIT 111 ML/MIN). THE PERFORMANCE TEST SHOWED THAT THE GAS TRANSFER RATE OF THE OXYGENATOR WAS WITHIN SPECIFICATION. A DEFINITIVE CAUSE FOR THE REPORTED LOW PO2 LEVELS COULD NOT BE DETERMINED. THE REPORTED POST-MEMBRANE PO2 VALUES CAN BE INFLUENCED BY MULTIPLE CLINICAL AND OPERATIONAL FACTORS UNRELATED TO DEVICE, WHICH MAY INCLUDE ECMO OPERATIONAL SETTINGS AND PROGRESSIVE CLOT BURDEN OR PROTEIN DEPOSITION WITHIN THE CIRCUIT OVER TIME.
Description of Event or Problem
A USER FACILITY REPORTED THAT A PATIENT WITH ACUTE RESPIRATORY DISTRESS SYNDROME AND INFLUENZA PNEUMONIA HAD A POST-OXYGENATOR ARTERIAL OXYGEN OF APPROXIMATELY 100 MMHG WITH 100% FRACTION OF INSPIRED OXYGEN UPON THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. UPON FOLLOW-UP, IT WAS REPORTED THAT THE XLUNG KIT WAS EXCHANGED FOR A NEW KIT, RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THE PATIENT REQUIRED AN ADJUSTMENT ON VENTILATION AS A RESULT OF THIS EVENT. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.
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 A PATIENT WITH ACUTE RESPIRATORY DISTRESS SYNDROME AND INFLUENZA PNEUMONIA HAD A POST-OXYGENATOR ARTERIAL OXYGEN OF APPROXIMATELY 100 MMHG WITH 100% FRACTION OF INSPIRED OXYGEN UPON THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.