XLUNG KIT 230
Received May 9, 2025 · Event occurred Apr 4, 2025
Report 3012172416-2025-00042 · MDR key 21994399
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXH1906
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
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5 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 THE POST-MEMBRANE OXYGEN PARTIAL PRESSURE REMAINED CONSISTENTLY AT 66.1 MMHG DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. DESPITE THE CLINICIAN'S ATTEMPTS TO REPLACE BOTH THE OXYGEN SUPPLY AND AIR-OXYGEN BLENDER, NO IMPROVEMENT IN THE PATIENT'S OXYGENATION WAS OBSERVED. UPON FOLLOW-UP, IT WAS REPORTED THE PATIENT'S OXYGENATION IMPROVED FOLLOWING EXCHANGE OF THE KIT. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE SAMPLE WAS DISCARDED AND UNAVAILABLE FOR PRODUCT EVALUATION.
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 THE POST-MEMBRANE OXYGEN PARTIAL PRESSURE REMAINED CONSISTENTLY AT 66.1 MMHG DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. DESPITE THE CLINICIAN'S ATTEMPTS TO REPLACE BOTH THE OXYGEN SUPPLY AND AIR-OXYGEN BLENDER, NO IMPROVEMENT IN THE PATIENT'S OXYGENATION WAS OBSERVED. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D3, G1. PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE INITIAL MEASURED BLOOD GAS VALUES INDICATE INADEQUATE OXYGEN TRANSFER. FURTHER SERIAL BLOOD GASES SHOWED A GRADUAL IMPROVEMENT IN OXYGENATION AND SATURATION OF OXYGEN WITH A CONCOMITANT REDUCTION IN CARBON DIOXIDE. THE DELAYED INCREASE IN OXYGENATION SUGGESTS THAT THE INITIAL PROBLEM WAS AN OXYGENATOR-RELATED ISSUE.
Description of Event or Problem
A USER FACILITY REPORTED THE POST-MEMBRANE OXYGEN PARTIAL PRESSURE REMAINED CONSISTENTLY AT 66.1 MMHG DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. DESPITE THE CLINICIAN'S ATTEMPTS TO REPLACE BOTH THE OXYGEN SUPPLY AND AIR-OXYGEN BLENDER, NO IMPROVEMENT IN THE PATIENT'S OXYGENATION WAS OBSERVED. UPON FOLLOW-UP, IT WAS REPORTED THE PATIENT'S OXYGENATION IMPROVED FOLLOWING EXCHANGE OF THE KIT. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE SAMPLE WAS DISCARDED AND UNAVAILABLE FOR PRODUCT EVALUATION.