XLUNG KIT 230

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN IFU AND/OR ON THE LABEL. QUALITY EVENTS MENTIONED IN THE RELEASE CERTIFICATE DO NOT REFER TO THE FAILURE PATTERN AT HAND. NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE WAS RECEIVED ON 24/OCT/2024 FOR PRODUCT INVESTIGATION. VISUAL INSPECTION OF THE PUMP HEAD REVEALED SCRATCH MARKS AT THE BASE OF THE INNER HOUSING. DURING FUNCTIONAL TESTING, THE ROTOR OF THE PUMP HEAD WAS TILTED TO ONE SIDE AND THE BASE OF THE ROTOR TOUCHED THE INNER HOUSING. THE ROTOR WAS ROTATING, HOWEVER, THE SOUND OF THE ROTOR SCRAPING AGAINST THE HOUSING AND A SCRAPING NOISE WAS AUDIBLE. THE PUMP HEAD WAS OPENED. SCRATCH MARKS ON THE BASE OF THE INNER HOUSING. IT WAS OBSERVED THAT THE PIN / CALOTTE WAS DAMAGED. THE BALL BEARING OF THE ROTOR WAS NOT DAMAGED; HOWEVER, AN EXCESS OF ADHESIVE WAS OBSERVED AROUND THE CERAMIC BALL AT THE TIP OF THE ROTOR. THIS COULD HAVE LED TO AN UNEVEN RUN OF THE ROTOR AND CAUSED DAMAGE TO THE PIN /CALOTTE DURING OPERATION. IT IS LIKELY THAT AN ERROR OCCURRED DURING GLUING OF THE CERAMIC BALL INTO THE ROTOR AND TOO MUCH GLUE ACCUMULATED AROUND THE CERAMIC BALL AT THE TIP OF THE ROTOR. THIS COULD HAVE CAUSED AN UNEVEN RUN AND DAMAGE TO THE PIN. ANOTHER CAUSE MAY BE AN INITIAL DEFECT IN THE HOUSING (PIN). HOWEVER, THIS CAN NO LONGER BE DETERMINED DUE TO THE DAMAGE.

Description of Event or Problem

A USER FACILITY REPORTED THAT AN ABNORMAL SOUND WAS NOTED AT THE PUMP HEAD OF THE XLUNG KIT 230 DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE PROVIDED VIDEO EVIDENCE SHOWED ACTIVE ECMO SUPPORT AND DEMONSTRATED A GRINDING SOUND WITH NO OBVIOUS VISIBLE DEFECT TO THE PUMP HEAD OR PUMP DRIVE. UPON FOLLOW UP, IT WAS REPORTED THE NOISE WAS COMING FROM THE PUMP HEAD AT 7500 TO 8000 RPM APPROXIMATELY FIVE DAYS AFTER THE START OF SUPPORT. THERE WAS NO NOISE NOTED DURING THE PRIMING PHASE. THE ROTOR OF THE HORIZONTALLY PLACED PUMP HEAD COULD NOT REMAIN STATIONARY DURING OPERATION. IT WAS UNKNOWN IF THE PUMP HEAD WAS SEATED PROPERLY AS INSTRUCTED IN THE OPERATION MANUAL. THE ISSUE WAS RESOLVED WITH A REDUCTION IN RPMS. THE PATIENT HAD APPROXIMATELY 50 ML OF BLOOD LOSS RESULTING. THE PATIENT EXPERIENCED HEMOGLOBINURIA AND WAS TREATED SYMPTOMATICALLY. THE SAMPLE PUMP HEAD WAS RETURNED FOR PRODUCT INVESTIGATION.