XLUNG KIT 230
Received Mar 28, 2025 · Event occurred Mar 11, 2025
Report 3012172416-2025-00031 · MDR key 21721781
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
Description of Event or Problem
A USER FACILITY REPORTED LEAKING PRIMING FLUID AT THE ARTERIAL TEMPERATURE MEASUREMENT PORT OF THE OXYGENATOR DURING PRIMING. TIGHTENING OF THE CONNECTIONS DID NOT FIX THE ISSUE. THE KIT WAS EXCHANGED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5, D4, D9, H3. PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. TREND ANALYSIS OF THIS BATCH SHOWED THREE SIMILAR COMPLAINTS. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION. A LEAKAGE TEST AT ABOUT 1 BAR WAS CARRIED OUT. A LIQUID LEAK OCCURRED AT THE RECIRCULATION PORT. NO LEAK WAS OBSERVED AT THE TEMPERATURE PORT. NO DAMAGE WAS VISIBLE AT THE RECIRCULATION PORT OR AT THE LUER ADAPTER OF THE ARTERIAL VENTING LINE. THE CAVITY NUMBER OF THE INJECTION MOLD OF THE LUER-LOCK POSITIVE ADAPTER IS 2. THE CAUSE OF THE LEAK IS A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT WHICH RESULTS IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. THE COMPLAINT WAS ASSIGNED TO AN EXISTING CAPA THAT WAS INITIATED AS A RESULT OF SIMILAR FAILURE PATTERNS.
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 PRIMING FLUID AT THE ARTERIAL TEMPERATURE MEASUREMENT PORT OF THE OXYGENATOR DURING PRIMING. TIGHTENING OF THE CONNECTIONS DID NOT FIX THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.