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 THAT THE MENTIONED XENIOS DEVICES HAVE BEEN USED ON A 13-YEAR-OLD PATIENT WITH SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). THE PATIENT WAS INITIALLY ON VENO-ARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THEN TRANSITIONED TO VENO-ARTERIAL VENOUS (VAV) ECMO SUPPORT WITH A FRACTION OF INSPIRED OXYGEN (FIO2) OF 100% FROM A GAS BLENDER AND THE SWEEP GAS VARIED FROM 3 TO 6 L/MIN. ECMO SUPPORT STARTED ON (B)(6) 2025, THE FOLLOWING WERE POST-OXYGENATOR GASES MEASURED SINCE THE BEGINNING OF SUPPORT (ALL IN MMHG): ON THURSDAY, (B)(6) 2025 - 272, 275, 370, 282, 371; ON FRIDAY (B)(6) 2025 - 418, 281; ON SATURDAY (B)(6) 2025 - 251, 247, 270; ON SUNDAY (B)(6) 2025 ¿ 184, 177. THE CIRCUIT WAS CHANGED WHICH RESULTED IN 234 AND 235. ON MONDAY (B)(6) 2025 - 201, 92, AND THE CIRCUIT WAS EXCHANGED AGAIN, RESULTING IN 156 AND 130. THE USER ADDED A BYPASS OXYGENATOR IN PARALLEL TO PROVIDE ADEQUATE OXYGENATION TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL THAT COULD PROVIDE ECMO SUPPORT WITH A COMPETITOR DEVICE (CARDIOHELP).

Description of Event or Problem

A USER FACILITY REPORTED THAT THE MENTIONED XENIOS DEVICES HAVE BEEN USED ON A 13-YEAR-OLD PATIENT WITH SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). THE PATIENT WAS INITIALLY ON VENO-ARTERIAL (VA) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THEN TRANSITIONED TO VENO-ARTERIAL VENOUS (VAV) ECMO SUPPORT WITH A FRACTION OF INSPIRED OXYGEN (FIO2) OF 100% FROM A GAS BLENDER AND THE SWEEP GAS VARIED FROM 3 TO 6 L/MIN. ECMO SUPPORT STARTED ON (B)(6) 2025, THE FOLLOWING WERE POST-OXYGENATOR GASES MEASURED SINCE THE BEGINNING OF SUPPORT (ALL IN MMHG): ON THURSDAY, (B)(6) 2025 - 272, 275, 370, 282, 371; ON FRIDAY (B)(6) 2025 - 418, 281; ON SATURDAY (B)(6) 2025 - 251, 247, 270; ON SUNDAY (B)(6) 2025 ¿ 184, 177. THE CIRCUIT WAS CHANGED WHICH RESULTED IN 234 AND 235. ON MONDAY (B)(6) 2025 - 201, 92, AND THE CIRCUIT WAS EXCHANGED AGAIN, RESULTING IN 156 AND 130. THE USER ADDED A BYPASS OXYGENATOR IN PARALLEL TO PROVIDE ADEQUATE OXYGENATION TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL THAT COULD PROVIDE ECMO SUPPORT WITH A COMPETITOR DEVICE (CARDIOHELP). THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3. PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS. INVESTIGATION OF THE RETURNED SAMPLES SHOWED THAT THE TRANSFER RATE FOR OXYGEN WAS WITHIN SPECIFICATION, AND NO EVIDENCE OF OXYGENATION IMPAIRMENT DUE TO DEVICE MALFUNCTION WAS IDENTIFIED. A MINOR CARBON DIOXIDE TRANSFER DEVIATION LIKELY REFLECTED MEASUREMENT VARIABILITY AND IS NOT EXPECTED TO AFFECT OXYGEN TRANSFER EFFICIENCY. A DEFINITIVE CAUSE FOR THE REPORTED SUBOPTIMAL OXYGENATION CANNOT BE DETERMINED. THE CAUSE FOR LOW POST-OXY PARTIAL OXYGEN PRESSURE OR LOW OXYGENATOR PERFORMANCE CAN BE PRODUCT AS WELL AS APPLICATION AND/OR PATIENT RELATED. THE ABSENCE OF DELTA PRESSURE INCREASES, OR VISUAL CLOTTING SUGGESTS NO SIGNIFICANT FIBER OBSTRUCTION OR THROMBUS FORMATION. GIVEN THE HIGH POST OXYGENATOR SATURATION OF OXYGEN OF 99% AND 100% AND SIMULTANEOUSLY LOW SYSTEMIC SAO2 (LOWEST 58%), POTENTIAL CONTRIBUTING FACTORS EXTERNAL TO THE OXYGENATOR MAY HAVE INFLUENCED OXYGEN DELIVERY SUCH ELEVATED OXYGEN CONSUMPTION OR SHUNT FRACTION ASSOCIATED WITH SEVERE ARDS.