XLUNG KIT 230
Received Aug 28, 2025 · Event occurred Aug 13, 2025
Report 3012172416-2025-00087 · MDR key 22911145
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXF2413
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
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 A PUMP HEAD HAD A THROMBOSIS ON A COMPETITOR SYSTEM, A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT HAD TO BE TRANSFERRED TO THE XENIOS CONSOLE. THE POST-OXYGENATOR ARTERIAL OXYGEN WAS ONLY 90 MMHG WHILE THE PATIE3NT RECEIVED 100% OXYGEN WITH A HEMOGLOBIN OF 8.5 MG/DL. AFTER TWO HOURS, THE PATIENT WAS RETURNED TO THE COMPETITOR SYSTEM. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT AFTER A PUMP HEAD HAD A THROMBOSIS ON A COMPETITOR SYSTEM, A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT HAD TO BE TRANSFERRED TO THE XENIOS CONSOLE. THE POST-OXYGENATOR ARTERIAL OXYGEN WAS ONLY 90 MMHG WHILE THE PATIENT RECEIVED 100% OXYGEN WITH A HEMOGLOBIN OF 8.5 MG/DL. AFTER TWO HOURS, THE PATIENT WAS RETURNED TO THE COMPETITOR SYSTEM. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, H6 PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS OF BATCH. NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. BASED ON THE BLOOD GAS ANALYSIS PROVIDED, THE ESTIMATED OXYGEN TRANSFER RATE WAS ABOUT 211 ML/MIN. THIS TRANSFER IS WITHIN EXPECTED RANGE. THE OXYGENATOR WAS RECEIVED ON (B)(6) 2025. IT HAD BEEN RINSED PRIOR TO SHIPPING AND WAS FOUND CLEAN, WITH NO VISIBLE BLOOD RESIDUES OR EXTERNAL DEFECTS. PERFORMANCE TESTING SHOWED THAT THE OXYGEN TRANSFER PERFORMANCE WAS WITHIN SPECIFICATION. WE THEREFORE CONCLUDE THAT THE OBSERVED RESULTS ARE MOST CONSISTENT WITH PATIENT OR CIRCUIT-RELATED FACTORS RATHER THAN A DEVICE DEFECT. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES.
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 A PUMP HEAD HAD A THROMBOSIS ON A COMPETITOR SYSTEM, A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT HAD TO BE TRANSFERRED TO THE XENIOS CONSOLE. THE POST-OXYGENATOR ARTERIAL OXYGEN WAS ONLY 90 MMHG WHILE THE PATIENT RECEIVED 100% OXYGEN WITH A HEMOGLOBIN OF 8.5 MG/DL. AFTER TWO HOURS, THE PATIENT WAS RETURNED TO THE COMPETITOR SYSTEM. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.