XLUNG KIT 230
Received Mar 20, 2025 · Event occurred Mar 3, 2025
Report 3012172416-2025-00028 · MDR key 21650957
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: B5, D4, D9 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. TWO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED FOR EVALUATION. SOME CRYSTALLIZATION WAS VISIBLE ON THE OUTSIDE OF THE OXYGENATOR HOUSING BETWEEN THE RECIRCULATION PORT AND CARDIOPLEGIA PORT, WHICH COULD BE DUE TO LEAKAGE OF THE PRIMING SOLUTION. ADDITIONALLY, A CRACK WAS OBSERVED IN THE LUER-LOCK NEGATIVE ADAPTER OF THE VENTING LINE, WHICH MAY HAVE ALSO RESULTED IN A LIQUID LEAK. FOR FURTHER TESTING, THE VENTING LINE WAS CLAMPED, AS LIQUID WAS LEAKING THROUGH THE CRACK. A SMALL LEAK WAS DETECTED AT THE CONNECTION AT THE RECIRCULATION PORT. NO DEFECT WAS VISIBLE AT THE PORT OR THE LUER-LOCK POSITIVE ADAPTER OF THE VENTING LINE. 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. ADDITIONALLY, A CRACK IN THE LUER-LOCK NEGATIVE ADAPTER WAS OBSERVED. THE COMPONENT IS A PURCHASED PART. DUE TO PREVIOUS COMPLAINTS A TOOL OPTIMIZATION WAS CARRIED ON PART OF THE SUPPLIER OUT IN JULY 2021. CRACKS IN THE LUER ADAPTER COULD BE DUE TO A PROBLEM WITH THE INJECTION MOLDING PROCESS. A CAPA WAS INITIATED TO ADDRESS THE ISSUE.
Description of Event or Problem
A USER FACILITY REPORTED A LEAKAGE OF THE OXYGENATOR. THE LEAKAGE WAS NOTED AT THE HOUSING COVER OF THE OXYGENATOR DURING PRIMING. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE PRODUCT WAS SEQUESTERED AND EXCHANGED FOR A NEW XLUNG KIT 230. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AND RETURNED TO XENIOS FOR 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 A LEAKAGE OF THE OXYGENATOR. THE LEAKAGE WAS NOTED AT THE HOUSING COVER OF THE OXYGENATOR DURING PRIMING. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.