XLUNG KIT 230
Received Sep 4, 2025 · Event occurred Aug 17, 2025
Report 3012172416-2025-00091 · MDR key 22962023
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
UNKNOWN
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 · Male
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED OXYGENATOR PERFORMANCE LOSS DURING VENOUS-ARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT DURING CARDIOPULMONARY RESUSCITATION UTILIZING THE XLUNG KIT 230. DURING RESUSCITATION AND INSTALLATION OF VA SUPPORT, NO OXYGENATION WAS POSSIBLE AND POST-OXYGENATOR ARTERIAL OXYGEN WAS BELOW 100 MMHG. AN IMMEDIATE CONVERSION TO ANOTHER DEVICE (CARDIOHELP) WAS PERFORMED DUE TO THE HECTIC SITUATION IN THE CARDIAC CARE UNIT/SHOCK ROOM. ONGOING RESUSCITATION WAS PERFORMED. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE 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 OXYGENATOR PERFORMANCE LOSS DURING VENOUS-ARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT DURING CARDIOPULMONARY RESUSCITATION UTILIZING THE XLUNG KIT 230. DURING RESUSCITATION AND INSTALLATION OF VA SUPPORT, NO OXYGENATION WAS POSSIBLE AND POST-OXYGENATOR ARTERIAL OXYGEN WAS BELOW 100 MMHG. AN IMMEDIATE CONVERSION TO ANOTHER DEVICE (CARDIOHELP) WAS PERFORMED DUE TO THE HECTIC SITUATION IN THE CARDIAC CARE UNIT/SHOCK ROOM. ONGOING RESUSCITATION WAS PERFORMED. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, H6. PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND NOT AVAILABLE FOR EVALUATION. THE BATCH OF THE PRODUCT IS UNKNOWN, AND NO FURTHER DETAILS CONCERNING THE PRODUCT WERE PROVIDED. SIMILAR COMPLAINTS FOLLOWING THE SAME FAILURE PATTERN HAVE PREVIOUSLY BEEN REPORTED. A FAILURE IN THE GAS EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL AND/OR FURTHER PROCESSING DURING MANUFACTURING OF THE OXYGENATOR. ADDITIONALLY, THE PERFORMANCE OF THE GAS EXCHANGER IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION, BLOOD FLOW AND SWEEP GAS FLOW.