NOVALUNG CONSOLE (LINUX BOARD)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: F6.

Description of Event or Problem

A CLINICAL SUPPORT SPECIALIST REPORTED THAT THIS 70-YEAR-OLD FEMALE CRITICALLY ILL PATIENT WAS STATUS-POST CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2025 WHO WAS DISCHARGED HOME AND DEVELOPED SEVERE RESPIRATORY FAILURE. EMERGENCY MEDICAL SERVICES TRANSPORTED THE PATIENT TO THE HOSPITAL ON (B)(6) 2026 WHERE THEY TESTED POSITIVE FOR INFLUENZA TYPES A AND B. THE PATIENT WAS CANNULATED FOR VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2026 AND EXPERIENCED SEVERE HYPOTENSION IN THE EARLY MORNING OF (B)(6) 2026 WHILE ON SUPPORT. IT WAS EXPLAINED THAT INITIAL REPORTS OF CARDIAC ARREST WERE FALSE AS THE PATIENT INSTEAD EXPERIENCED SEVERE HYPOTENSION THAT REQUIRED A CHANGE IN ECMO MODALITY FOR CARDIOPULMONARY SUPPORT. AS A RESULT, THE PATIENT WAS TRANSITIONED TO VENO-VENOARTERIAL ECMO SUPPORT ON THE SAME DEVICE AND PATIENT CIRCUIT. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX DEVICE (NOT A FRESENIUS/XENIOS PRODUCT) THAT WAS INITIATED FOR RENAL SUPPORT. THE FILTER OF THE COMPETITOR CRRT DEVICE CLOTTED AND WAS CHANGED OUT THAT MORNING. PLASMA FREE HGB LEVELS WERE CHECKED AND RESULTED AT GREATER THAN 500 MG/DL AFTER RECEIVING VARIOUS BLOOD PRODUCTS. IT WAS DETERMINED BY THE USER FACILITY THAT THE CLOTTING OF THE CRRT DEVICE WAS FROM MULTIPLE BLOOD PRODUCTS AND UNRELATED TO THE PERFORMANCE OF THE NOVALUNG CONSOLE OR ASSOCIATED XENIOS PRODUCTS. ECMO SUPPORT WAS DISCONTINUED BY DECISION OF THE FAMILY ON THE EVENING OF 21/JAN/2026, AND THE PATIENT SUBSEQUENTLY EXPIRED APPROXIMATELY TWO HOURS FOLLOWING DISCONTINUATION OF SUPPORT. IT WAS REPORTED THAT THE PATIENT¿S VIRAL INFECTION LEADING TO SEVERE HYPOTENSION AND RESPIRATORY FAILURE, THE ASSOCIATED HOSPITALIZATION, CLOTTING OF THE COMPETITOR CRRT DEVICE AND THE PATIENT¿S SUBSEQUENT DEATH WERE NOT THE RESULT OF A DEFICIENCY OR MALFUNCTION OF ANY XENIOS PRODUCT(S) OR DEVICE(S). THE CSS REPORTED THAT NO XENIOS PRODUCTS WILL BE RETURNED FOR EVALUATION AND THE SAME NOVALUNG DEVICE WAS PRIMED AND UTILIZED FOR A DIFFERENT PATIENT THE FOLLOWING DAY WITHOUT INCIDENT.

Description of Event or Problem

A CLINICAL SUPPORT SPECIALIST REPORTED THAT THIS 70-YEAR-OLD FEMALE CRITICALLY ILL PATIENT WAS STATUS-POST CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2025 WHO WAS DISCHARGED HOME AND DEVELOPED SEVERE RESPIRATORY FAILURE. EMERGENCY MEDICAL SERVICES TRANSPORTED THE PATIENT TO THE HOSPITAL ON (B)(6) 2026 WHERE THEY TESTED POSITIVE FOR INFLUENZA TYPES A AND B. THE PATIENT WAS CANNULATED FOR VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2026 AND EXPERIENCED SEVERE HYPOTENSION IN THE EARLY MORNING OF (B)(6) 2026 WHILE ON SUPPORT. IT WAS EXPLAINED THAT INITIAL REPORTS OF CARDIAC ARREST WERE FALSE AS THE PATIENT INSTEAD EXPERIENCED SEVERE HYPOTENSION THAT REQUIRED A CHANGE IN ECMO MODALITY FOR CARDIOPULMONARY SUPPORT. AS A RESULT, THE PATIENT WAS TRANSITIONED TO VENO-VENOARTERIAL ECMO SUPPORT ON THE SAME DEVICE AND PATIENT CIRCUIT. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX DEVICE (NOT A FRESENIUS/XENIOS PRODUCT) THAT WAS INITIATED FOR RENAL SUPPORT. THE FILTER OF THE COMPETITOR CRRT DEVICE CLOTTED AND WAS CHANGED OUT THAT MORNING. PLASMA FREE HGB LEVELS WERE CHECKED AND RESULTED AT GREATER THAN 500 MG/DL AFTER RECEIVING VARIOUS BLOOD PRODUCTS. IT WAS DETERMINED BY THE USER FACILITY THAT THE CLOTTING OF THE CRRT DEVICE WAS FROM MULTIPLE BLOOD PRODUCTS AND UNRELATED TO THE PERFORMANCE OF THE NOVALUNG CONSOLE OR ASSOCIATED XENIOS PRODUCTS. ECMO SUPPORT WAS DISCONTINUED BY DECISION OF THE FAMILY ON THE EVENING OF (B)(6) 2026, AND THE PATIENT SUBSEQUENTLY EXPIRED APPROXIMATELY TWO HOURS FOLLOWING DISCONTINUATION OF SUPPORT. IT WAS REPORTED THAT THE PATIENT¿S VIRAL INFECTION LEADING TO SEVERE HYPOTENSION AND RESPIRATORY FAILURE, THE ASSOCIATED HOSPITALIZATION, CLOTTING OF THE COMPETITOR CRRT DEVICE AND THE PATIENT¿S SUBSEQUENT DEATH WERE NOT THE RESULT OF A DEFICIENCY OR MALFUNCTION OF ANY XENIOS PRODUCT(S) OR DEVICE(S). THE CSS REPORTED THAT NO XENIOS PRODUCTS WILL BE RETURNED FOR EVALUATION AND THE SAME NOVALUNG DEVICE WAS PRIMED AND UTILIZED FOR A DIFFERENT PATIENT THE FOLLOWING DAY WITHOUT INCIDENT.