XLUNG KIT 230

Additional Manufacturer Narrative

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. FIVE OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS UNAVAILABLE AND NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, IT IS ASSUMED THAT A SMALL AMOUNT OF PRIMING LIQUID LEAKED FROM THE RECIRCULATION PORT OF THE OXYGENATOR AND DRIED WHICH CAUSED CRYSTALLIZATION. THE SOURCE OF THE POSSIBLE LEAK AT THIS LOCATION HAS BEEN IDENTIFIED DURING INVESTIGATION OF SIMILAR COMPLAINTS. IT WAS FOUND THAT THERE WAS A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT RESULTING IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. THIS DEVIATION HAS SINCE BEEN CORRECTED, AND A CAPA WAS INITIATED TO ADDRESS THE ISSUE.

Description of Event or Problem

A USER FACILITY REPORT THAT AN UNUSUAL WHITE SUBSTANCE (RESIDUE) ACCUMULATED ON THE SURFACE OF THE OXYGENATOR THAT WAS DETECTED DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. NO LEAK WAS NOTICED DURING PRIMING OR DURING ECMO SUPPORT. FOLLOWING THE LOCAL INVESTIGATION, IT WAS DETERMINED THE WHITE SUBSTANCE WAS CRYSTALIZED PRIMING FLUID THAT MAY HAVE LEAKED DURING PRIMING OF THE PATIENT CIRCUIT PRIOR TO SUPPORT START. THERE WAS NO RESULTING INJURY OR CONSEQUENCE TO THE PATIENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.