XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. ONE SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION. THERE WAS NO VISIBLE DAMAGE TO THE RECIRCULATION PORT OR TO THE LUER-LOCK ADAPTER OF THE ARTERIAL VENTING LINE. A LEAKAGE TEST WAS CARRIED OUT AT ABOUT 1 BAR. A LEAKAGE TEST REVEALED A LIQUID LEAK COMING FROM THE RECIRCULATION PORT OF THE OXYGENATOR. AFTER ABOUT AN HOUR A SMALL LIQUID LEAK WAS VISIBLE AT THE RECIRCULATION PORT. NO DEFECT WAS VISIBLE AT THE RECIRCULATION PORT OR THE CONNECTED LUER-LOCK ADAPTER. IT WAS DETERMINED THAT THE CAUSE OF THE LEAK IS A MINIMAL DEVIATION IN DIMENSIONS OF THE RECIRCULATION PORT WHICH RESULTS IN A VERY SMALL GAP THROUGH WHICH LIQUID CAN LEAK. ALTHOUGH OUR OXYGENATORS ARE 100% LEAK TESTED, IN A FEW CASES LEAKAGE MAY OCCUR DUE TO ADVERSE ENVIRONMENTAL CONDITIONS OR MECHANICAL STRESS DURING TRANSPORTATION.

Description of Event or Problem

A USER FACILITY REPORTED A LEAKAGE AT THE RECIRCULATION PORT OF THE OXYGENATOR DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50 ML AS A RESULT. REPLACEMENT OF THE XLUNG KIT WAS DETERMINED TO BE UNNECESSARY. THE PATIENT WAS WEANED OFF ECMO SUPPORT ON THE SAME KIT WITHOUT COMPLICATION. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED A LEAKAGE AT THE RECIRCULATION PORT OF THE OXYGENATOR DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.