XLUNG KIT 230
Received Aug 28, 2025 · Event occurred Aug 13, 2025
Report 3012172416-2025-00089 · MDR key 22911325
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
GSXC1711
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT FOLLOWING AN INITIALLY ACCEPTABLE POST-OXYGENATOR ARTERIAL BLOOD GAS, THERE WAS A SUBSEQUENT AND UNEXPLAINED DROP IN OXYGENATION PERFORMANCE WITH STABLE CARBON DIOXIDE ELIMINATION. THROUGH THE COURSE OF SUPPORT, THERE WAS A BRIEF IMPROVEMENT IN OXYGENATION FOLLOWED BY ANOTHER UNEXPLAINED DROP IN OXYGENATOR PERFORMANCE. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: UPON FURTHER REVIEW AND CORRESPONDENCE FROM THE MANUFACTURER, IT HAS BEEN DETERMINED THAT THE EVENT REPORTED IN MFR REPORT # 3012172416-2025-00089 WAS A DUPLICATE OF THE EVENT REPORTED IN 3012172416-2025-00085. THE NOTICE OF DUPLICATION WAS REPORTED BY THE MANUFACTURER COMPLAINT MANAGER. THERE WILL BE NO FURTHER UPDATES ON 3012172416-2025-00089, WHICH HAS BEEN DEEMED A DUPLICATE COMPLAINT.
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 FOLLOWING AN INITIALLY ACCEPTABLE POST-OXYGENATOR ARTERIAL BLOOD GAS, THERE WAS A SUBSEQUENT AND UNEXPLAINED DROP IN OXYGENATION PERFORMANCE WITH STABLE CARBON DIOXIDE ELIMINATION. THROUGH THE COURSE OF SUPPORT, THERE WAS A BRIEF IMPROVEMENT IN OXYGENATION FOLLOWED BY ANOTHER UNEXPLAINED DROP IN OXYGENATOR PERFORMANCE. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.