XLUNG KIT 230

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 HOUSING COVER OF THE OXYGENATOR DURING PRIMING OF THE CIRCUIT. UPON FOLLOW-UP, IT WAS REPORTED THE LEAK WAS LOCATED ABOVE THE TEMPERATURE SENSOR CONNECTION. THERE WAS NO INDICATION OF PATIENT IMPACT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AND RETURNED TO XENIOS ON 31/JAN/2025.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, 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. THE SAMPLE WAS RETURNED AND RECEIVED ON JANUARY 31, 2025. A LEAK WAS FOUND IN THE RECIRCULATION PORT OF THE OXYGENATOR RESULTING IN FLUID RUNNING DOWN THE CARDIOPLEGIA AND TEMPERATURE PORT. THERE WAS NO VISUAL DEFECT AT THE PORT AND NO DEFECT WAS OBSERVED AT THE LUER-LOCK ADAPTER (CAVITY NUMBER OF THE INJECTION MOLD OF THE LUER-LOCK POSITIVE ADAPTER IS 9). THE CAUSE OF LEAKS AT THE RECIRCULATION PORT HAS BEEN IDENTIFIED DURING INVESTIGATION OF PREVIOUS COMPLAINTS. THE LEAK IS CAUSED BY MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT. THIS RESULTS IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. A CAPA WAS PREVIOUSLY INITIATED TO ADDRESS THE ISSUE.

Description of Event or Problem

A USER FACILITY REPORTED A LEAKAGE OF THE HOUSING COVER OF THE OXYGENATOR DURING PRIMING OF THE CIRCUIT. UPON FOLLOW-UP, IT WAS REPORTED THE LEAK WAS LOCATED ABOVE THE TEMPERATURE SENSOR CONNECTION. THERE WAS NO INDICATION OF PATIENT IMPACT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION AND RETURNED TO XENIOS ON 31/JAN/2025.