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 LEAKAGE AT THE RECIRCULATION PORT OF THE OXYGENATOR AFTER 45 MINUTES OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT DESPITE THE LEAKAGE TESTING THAT PASSED DURING THE PREPARATION PHASE. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 500 ML. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D3, D4, G1. PLANT INVESTIGATION: THREE OTHER SIMILAR COMPLAINTS HAVE 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 NOT AVAILABLE FOR EVALUATION. A PHOTO HAS BEEN PROVIDED SHOWING A BLOOD LEAK THAT IS COMING FROM THE RECIRCULATION PORT. BASED ON THE INFORMATION PROVIDED, IT IS ASSUMED THAT THE LEAK WAS CAUSED BY MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT. THE LEAK 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 LEAKAGE AT THE RECIRCULATION PORT OF THE OXYGENATOR AFTER 45 MINUTES OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT DESPITE THE LEAKAGE TESTING THAT PASSED DURING THE PREPARATION PHASE. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 500 ML DUE TO XLUNG KIT 230 EXCHANGE. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.