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 FROM THE VENOUS VENTING PORT DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION, B5, D4 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON DECEMBER 3, 2025. THE TUBING SET ARRIVED FILLED WITH FLUID. THE LUER-LOCK POSITIVE ADAPTER, WHICH WAS ATTACHED TO THE VENOUS VENTING PORT, SHOWED SIGNS OF CLAMP MARKS ON THE OUTSIDE, AND THE INNER CONE WAS DEFORMED. HOWEVER, DURING LEAK TEST AT APPROXIMATELY 1 BAR, NO LEAKAGE WAS DETECTED. ALL OXYGENATORS ARE TESTED FOR LEAKAGES DURING IN-PROCESS CONTROLS. IT IS POSSIBLE THAT FINE CRACKS MAY SUBSEQUENTLY OCCUR DURING TRANSPORT OR HANDLING. ALTHOUGH OXYGENATORS ARE 100% LEAK TESTED, LEAKS MAY OCCUR IN FEW CASES DUE TO ADVERSE ENVIRONMENTAL CONDITIONS, FRICTION BETWEEN THE FIBERS DURING USE, OR MECHANICAL STRESS DURING TRANSPORTATION. THE ISSUE WILL CONTINUE TO BE MONITORED.

Description of Event or Problem

A USER FACILITY REPORTED A LEAKAGE FROM THE VENOUS VENTING PORT DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.