XLUNG KIT 230
Received Jan 21, 2025 · Event occurred Jan 6, 2025
Report 3012172416-2025-00008 · MDR key 21199576
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXD2216
Product problems
- Leak/Splash
- Mechanical Problem
- Leak/Splash
- Mechanical Problem
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4 PLANT INVESTIGATION: THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE AND/OR ON THE LABEL. DOCUMENTATION OF MODULE PRODUCTION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. ONE OTHER SIMILAR COMPLAINT HAS BEEN REPORTED FOR THIS BATCH NUMBER. NO SAMPLE WAS RETURNED FOR EVALUATION. A SAMPLE OF THE SAME BATCH SHOWED A SMALL LEAK AT THE RECIRCULATION PORT IN A PREVIOUS COMPLAINT. BASED ON THE AVAILABLE INFORMATION, IT IS ASSUMED THAT THE LEAKS WERE COMING FROM THE RECIRCULATION PORT OF THE OXYGENATOR. THE CAUSE HAS BEEN IDENTIFIED DURING INVESTIGATION OF SIMILAR COMPLAINTS AND A QUALITY EVENT WAS OPENED FOR FURTHER INVESTIGATION.
Description of Event or Problem
A USER FACILITY REPORTED LEAKING FLUID FROM THE OXYGENATOR. VISIBLE CRYSTALLIZATION AROUND THE P2 PORT AND BLOOD OUTLET WAS REPORTED. THE CIRCUIT WAS PRIMED AND ON STANDBY FOR SEVERAL DAYS BEFORE THE INCIDENT. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE 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 LEAKING FLUID FROM THE OXYGENATOR. VISIBLE CRYSTALLIZATION AROUND THE P2 PORT AND BLOOD OUTLET WAS REPORTED. THE CIRCUIT WAS PRIMED AND ON STANDBY FOR SEVERAL DAYS BEFORE THE INCIDENT. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.