XLUNG KIT 230
Received Aug 28, 2025 · Event occurred Aug 12, 2025
Report 3012172416-2025-00085 · MDR key 22911000
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXC1710
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
76 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT SINCE THE START OF THE VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE USER NOTICED A GREAT VARIATION IN POST-OXYGENATOR ARTERIAL OXYGEN VALUES. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE PATIENT WAS ABLE TO CONTINUE ECMO SUPPORT UTILIZING THE SAME XLUNG KIT 230. ARTERIAL BLOOD GAS TRENDING PROVIDED IN FOLLOW-UP SHOWED A VARIATION OF ARTERIAL OXYGEN ONLY WHEN THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS REDUCED FROM 100% TO 50%. ONCE THE FIO2 WAS INCREASED TO 70% BASED ON THE NEEDS OF THE PATIENT, ARTERIAL OXYGEN RETURNED TO INTENDED SUPPORTIVE LEVELS. THE COMPLAINT SAMPLE WAS RETURNED TO XENIOS FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: A2, B5, D9 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
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 SINCE THE START OF THE VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED A GREAT VARIATION IN POST-OXYGENATOR ARTERIAL OXYGEN VALUES. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT SINCE THE START OF THE VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE USER NOTICED A GREAT VARIATION IN POST-OXYGENATOR ARTERIAL OXYGEN VALUES. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE PATIENT WAS ABLE TO CONTINUE ECMO SUPPORT UTILIZING THE SAME XLUNG KIT 230. ARTERIAL BLOOD GAS TRENDING PROVIDED IN FOLLOW-UP SHOWED A VARIATION OF ARTERIAL OXYGEN ONLY WHEN THE THE FRACTION OF INSPIRED OXYGEN (FIO2) WAS REDUCED FROM 100% TO 50%. ONCE THE FIO2 WAS INCREASED TO 70% BASED ON THE NEEDS OF THE PATIENT, ARTERIAL OXYGEN RETURNED TO INTENDED SUPPORTIVE LEVELS. THE COMPLAINT SAMPLE WAS RETURNED TO XENIOS FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, H6 PLANT INVESTIGATION: NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER, AND THE REVIEW OF THE BATCH DOCUMENTATION DID NOT REVEAL ANY NON-CONFORMITY DURING THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE WAS RECEIVED ON (B)(6) 2025. THE SAMPLE ARRIVED WITH BLOOD RESIDUES IN THE OXYGENATOR. REMAINING BLOOD WAS REMOVED BY RINSING THE OXYGENATOR; HOWEVER, CLOTS REMAINED IN THE GAS EXCHANGER AND THE HEAT EXCHANGER OF THE OXYGENATOR. IT IS UNKNOWN IF CLOTTING OCCURRED DURING SUPPORT OR DURING STORAGE AFTER TREATMENT. THE PERFORMANCE TEST FOR GAS EXCHANGE COULD NOT BE PERFORMED. DUE TO THE INCREASED RESISTANCE IN THE OXYGENATOR, POTENTIALLY CAUSED BY CLOT FORMATION, THE TARGET SPEED OF 3 L/MIN COULD NOT BE REACHED. THE DATA PROVIDED SHOWED SERIAL BLOOD GASES HAD LARGE SWINGS IN POST-OXYGENATOR ARTERIAL OXYGEN. THIS TRANSFER IS WITHIN EXPECTED PHYSIOLOGIC RANGE FOR THE REPORTED FLOW AND SUPPORTS EFFECTIVE OXYGENATOR FUNCTION AT THAT TIME. THE LARGE VARIATION IN POST-OXYGENATOR PAO2 CAN BE EXPLAINED BY SAMPLING VARIABILITY, AND FIO2 ADJUSTMENTS. OXYGENATOR THROMBOSIS MAY BE CONTRIBUTING FACTOR THAT CANNOT BE RULED OUT SINCE THE RETURNED OXYGENATOR SHOWED CLOTS IN THE GAS EXCHANGER AND HEAT EXCHANGER THAT OBSTRUCTED THE FLOW.