XLUNG KIT 230
Received Jun 17, 2025 · Event occurred May 28, 2025
Report 3012172416-2025-00054 · MDR key 22224624
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXF1713
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
Description of Event or Problem
A USER FACILITY REPORTED THAT AFTER REPLACING THE OXYGENATOR TO THE XENIOS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DEVICE, THE POST-OXYGENATOR PRESSURE OF ARTERIAL OXYGEN IS SIGNIFICANTLY LOWER THAN IT WAS PREVIOUSLY WITH THE ROTAFLOW 2 ECMO DEVICE. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D3, D4, G1. PLANT INVESTIGATION: NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER, AND A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. 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 AFFECTED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION AND A DEFINITIVE CAUSE FOR THE LOW POST-OXY PO2 VALUE COULD NOT BE DETERMINED. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES.
Description of Event or Problem
A USER FACILITY REPORTED THAT AFTER REPLACING THE OXYGENATOR TO THE XENIOS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DEVICE, THE POST-OXYGENATOR PRESSURE OF ARTERIAL OXYGEN IS SIGNIFICANTLY LOWER THAN IT WAS PREVIOUSLY WITH THE ROTAFLOW 2 ECMO DEVICE. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.