XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3, H6 PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS OF BATCH: FSXH2601. NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE OXYGENATOR WAS RECEIVED ON NOVEMBER 12, 2025. THE SAMPLE ARRIVED WITH BLOOD RESIDUES IN THE OXYGENATOR. NO VISIBLE EXTERNAL DEFECTS WERE FOUND. MOST OF THE REMAINING BLOOD RESIDUE COULD BE REMOVED BY FLUSHING. HOWEVER, IN SOME AREAS OF THE GAS EXCHANGE MEMBRANE AND IN THE HEAT EXCHANGER OF THE OXYGENATOR COAGULATED BLOOD WAS STILL VISIBLE. THE PERFORMANCE TEST SHOWED THAT THE OXYGENATOR´S OXYGEN TRANSFER RATE WAS WITHIN SPECIFICATION. PRESSURE MEASUREMENT SHOWED AN ELEVATED DELTA P (PRESSURE DIFFERENCE BETWEEN PRE-OXYGENATOR AND POST-OXYGENATOR) OF 80 MMHG AT 3 L/MIN, INDICATING AN OBSTRUCTION IN THE OXYGENATOR. IT IS UNKNOWN WHEN OR HOW THIS OBSTRUCTION DEVELOPED, OR WHETHER IT WAS DURING OR AFTER TERMINATION OF SUPPORT; HOWEVER, IT MAY CONTRIBUTE TO LOWER-THAN-EXPECTED POST-OXYGENATOR ARTERIAL OXYGEN. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES.

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED A LOW POST-OXYGENATOR ARTERIAL OXYGEN OF INITIALLY LESS THAN 200 MMHG AND AFTER 20 MINUTES OF SUPPORT, LESS THAN 150 MMHG. AFTER ONE HOUR, THE SYSTEM WAS EXCHANGED. THE NEW OXYGENATOR WORKED FOR ABOUT A DAY AND AFTER THIS DAY SHOWED AN ARTERIAL OXYGEN OF LESS THAN 200 MMHG. BECAUSE THE PATIENT NEEDED A HIGH FLOW RATE, THE DEVICE WAS SWITCHED TO CARDIOHELP, WHICH SHOWED NO PROBLEMS WITH OXYGENATION. BOTH COMPLAINT SAMPLE XLUNG KITS WERE RETURNED FOR PRODUCT INVESTIGATION. THERE WAS NO PATIENT SERIOUS INJURY.

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED A LOW POST-OXYGENATOR ARTERIAL OXYGEN OF INITIALLY LESS THAN 200 MMHG AND AFTER 20 MINUTES OF SUPPORT, LESS THAN 150 MMHG. AFTER ONE HOUR, THE SYSTEM WAS EXCHANGED. THE NEW OXYGENATOR WORKED FOR ABOUT A DAY AND AFTER THIS DAY SHOWED AN ARTERIAL OXYGEN OF LESS THAN 200 MMHG. BECAUSE THE PATIENT NEEDED A HIGH FLOW RATE, THE DEVICE WAS SWITCHED TO CARDIOHELP, WHICH SHOWED NO PROBLEMS WITH OXYGENATION. BOTH COMPLAINT SAMPLE XLUNG KIT 230S (SAME LOT) ARE BEING RETURNED. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY.

Additional Manufacturer Narrative

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