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 THAT WHILE THE KIT WAS CONNECTED TO A PATIENT AND THE TEAM INITIATED EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, BLOOD SPURTED FROM THE TEMPERATURE CONNECTOR. THE KIT WAS REPLACED. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D3, D4, D9, H3. PLANT INVESTIGATION: NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER, AND A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE WAS RECEIVED ON JULY 7, 2025. DURING LEAKAGE TESTING, NO LEAK COULD BE FOUND AT THE TEMPERATURE PORT. HOWEVER, A SMALL LEAK WAS DISCOVERED AT THE RECIRCULATION PORT. IT WAS FOUND THAT THE LEAK WAS CAUSED BY A SMALL CRACK AT THE RECIRCULATION PORT. NO DAMAGE WAS FOUND AT THE LUER-LOCK ADAPTER OF THE VENTING LINE WHICH WAS CONNECTED TO THE PORT. THE CRACK MAY HAVE BEEN SUBSEQUENTLY CAUSED BY THE RELEASE OF MATERIAL STRESS, FOR EXAMPLE DURING HANDLING, E.G. TIGHTENING OF THE CONNECTION OR TRANSPORT. POTENTIAL ROOT CAUSES DURING PRODUCTION HAVE BEEN ANALYZED, AND MEASURES ARE BEING IMPLEMENTED.

Description of Event or Problem

A USER FACILITY REPORTED THAT WHILE THE KIT WAS CONNECTED TO A PATIENT AND THE TEAM INITIATED EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, BLOOD SPURTED FROM THE TEMPERATURE CONNECTOR. THE KIT WAS REPLACED AS A RESULT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.