XLUNG KIT 230
Received Jun 27, 2025 · Event occurred Jun 6, 2025
Report 3012172416-2025-00058 · MDR key 22344430
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXF1713
Product problems
- Fluid/Blood Leak
- Leak/Splash
- Incorrect Measurement
- Output Problem
- Fluid/Blood Leak
- Leak/Splash
- Incorrect Measurement
- Output Problem
Patient
NA · Female
- 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 SHORTLY AFTER THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE GAS EXCHANGE PERFORMANCE OF THE OXYGENATOR WAS TOO LOW. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
Description of Event or Problem
A USER FACILITY REPORTED THAT SHORTLY AFTER THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE GAS EXCHANGE PERFORMANCE OF THE OXYGENATOR WAS TOO LOW. THE FACILITY EXCHANGED THE OXYGENATOR RESULTING IN BLOOD LOSS. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D3, D4, G1, H6. PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. ONE OTHER SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE AFFECTED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION, AND A DEFINITIVE CAUSE FOR THE LOW POST-OXYGENATOR ARTERIAL OXYGENATION VALUE COULD NOT BE DETERMINED. A FAILURE IN THE GAS EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL OR FURTHER PROCESSING DURING MANUFACTURING OF THE OXYGENATOR. ADDITIONALLY, THE PERFORMANCE OF THE GAS EXCHANGER IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION (ACT, APTT), BLOOD FLOW, SWEEP GAS FLOW AND FRACTION OF INSPIRED OXYGEN. CLOTTING OF THE OXYGENATOR CAN NEGATIVELY IMPACT GAS EXCHANGE. ADDITIONALLY, HIGH BLOOD LEVELS OF FATS (HIGH SERUM LIPID LEVELS, E.G. AS A RESULT OF INTRAVENOUS NUTRITION WITH LIPIDS OR SEDATION WITH PROPOFOL) OR HIGH FIBRINOGEN CAN LEAD TO SECONDARY MEMBRANE FORMATION IN THE OXYGENATOR WHICH MAY RESULT IN IMPAIRED GAS EXCHANGE. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES.