XLUNG KIT 230

Additional Manufacturer Narrative

CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN ECMO SUPPORT UTILIZING THE XLUNG KIT 230 AND THE PATIENT¿S CARDIAC ARREST LEADING TO THEIR DEATH. THE CAUSE OF THIS PATIENT¿S CARDIAC ARREST WAS ATTRIBUTED TO A MALFUNCTION DURING ECMO SUPPORT IN WHICH THE PATIENT EXPERIENCED INADEQUATE BLOOD FLOW FOR AN EXTENDED PERIOD OF TIME AS REPORTED BY THE LOCAL COMPLAINT HANDING UNIT. IT IS WELL KNOWN THAT PATIENTS ON ECMO SUPPORT HAVE A SIGNIFICANTLY HIGH RISK FOR MORTALITY FOLLOWING OUT-OF-HOSPITAL CARDIAC ARRESTS WITH ECMO-ASSISTED CPR. ADDITIONALLY, CEREBRAL EDEMA IS FOUND TO BE ONE OF THE MOST SIGNIFICANT CONSEQUENCES LEADING TO DEATH FOR ECMO SUPPORTED PATIENTS. AS THE SOURCE OF THE MALFUNCTION OF THE OXYGENATOR REMAINS UNKNOWN, THE XLUNG KIT 230 CANNOT BE EXCLUDED AS A POTENTIAL SOURCE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENTS. BASED ON THE AVAILABLE INFORMATION, THOUGH AN ALLEGATION EXISTS THAT STATED THIS EVENT INVOLVED THE PERFORMANCE OF THE XLUNG KIT 230, THERE WAS NO OBJECTIVE EVIDENCE PROVIDED THAT INDICATED A FRESENIUS/XENIOS DEVICE(S) OR PRODUCT(S) DEFICIENCY OR MALFUNCTION, CAUSED OR CONTRIBUTED TO THE PATIENT¿S ADVERSE EVENTS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE REASSESSED AND UPDATED ACCORDINGLY. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

ON 26/NOV/2025, FRESENIUS BECAME AWARE OF THIS CRITICALLY ILL MALE PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT UTILIZING THE XLUNG KIT 230 WHO EXPIRED FOLLOWING INADEQUATE BLOOD FLOW. THERE WAS AN INFERRED ALLEGATION THAT THIS EVENT WAS DUE TO THE PERFORMANCE OF THE XLUNG KIT 230 IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE XENIOS COMPLAINT HANDLING UNIT, IT WAS REPORTED THIS PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AT 14:00 (ALL REPORTED TIMES LOCAL) ON (B)(6) 2025 DUE TO AN UNEXPLAINED SUDDEN CARDIAC ARREST AND COMA, FOLLOWED BY ONSITE CARDIOPULMONARY RESUSCITATION (CPR) AND EMERGENCY TRANSFER TO THE HOSPITAL. UPON ADMISSION, THE PATIENT EXPERIENCED A RETURN OF SYSTEMIC CIRCULATION, AND VENO-ARTERIAL (VA) ECMO SUPPORT WAS INITIATED. THE PATIENT'S SYSTEMIC CIRCULATION HAD BEEN RESTORED, BUT DUE TO CIRCULATORY FAILURE, BLOOD PRESSURE COULD NOT BE MAINTAINED WITH HIGH-DOSE VASOPRESSORS. A PREEMPTIVE COMPUTED TOMOGRAPHY (CT) MEDICAL IMAGING SCAN PERFORMED AT 21:00 ON THE SAME DAY SHOWED NO SIGNIFICANT ABNORMALITIES ON NON-CONTRAST HEAD CT. ON (B)(6) 2025 AT 10:00, THE ECMO MACHINE UNEXPECTEDLY STOPPED PUMPING, AND AN ABNORMAL SOUND OCCURRED. BEFORE THIS EVENT, THE ROTATIONAL SPEED WAS 7,000 RPM. AFTER THE NOISE OCCURRED, THE PUMP NEARLY STOPPED AS THE PHYSICIAN INCREASED THE PUMP SPEED TO 10,000 RPM, WHICH PRODUCED AN INADEQUATE BLOOD FLOW RATE OF 0.6 L/MIN. THE SOURCE OF THE ABNORMAL NOISE AND DECREASED BLOOD FLOW RATE WAS UNKNOWN. AT 10:10, THE PATIENT EXPERIENCED A CARDIAC ARREST. BY 11:30, THE OXYGENATOR WAS SUCCESSFULLY REPLACED, RESULTING IN PATIENT BLOOD LOSS OF APPROXIMATELY 500 ML. VASCULAR CANNULAS WERE INSPECTED AT THE TIME OF KIT EXCHANGE, AND NO EMBOLI WERE NOTED. ECMO SUPPORT WAS RESTARTED WITH A BLOOD FLOW RATE OF 3.6 L/MIN AND A PUMP SPEED OF 7500 RPM. BY 11:31 ON THE SAME DAY, THE PATIENT'S BLOOD PRESSURE, OXYGEN SATURATION, AND HEART RATE WERE RESTORED TO EXPECTED VALUES. A FOLLOW-UP HEAD CT ON (B)(6) 2025 REVEALED GLOBAL CEREBRAL SWELLING, INDICATING THE HIGH LIKELIHOOD OF BRAIN DEATH. THE PATIENT¿S POTENTIAL BRAIN DEATH WAS DETERMINED TO BE DIRECTLY RELATED TO THE MALFUNCTION ON (B)(6) 2025 DUE TO THE PROLONGED TROUBLESHOOTING PROCESS AND THE EXTENDED DURATION OF THE PATIENT¿S CARDIAC ARREST. GIVEN ABNORMAL ELECTROENCEPHALOGRAM FINDINGS AND THE HIGH LIKELIHOOD OF BRAIN DEATH, THE FAMILY DECIDED TO WITHDRAW SUPPORT ON (B)(6) 2025, AND THE PATIENT EXPIRED FOLLOWING TERMINATION OF SUPPORT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN ECMO SUPPORT UTILIZING THE XLUNG KIT 230 AND THE PATIENT¿S CARDIAC ARREST LEADING TO THEIR DEATH. THE CAUSE OF THIS PATIENT¿S CARDIAC ARREST WAS ATTRIBUTED TO A MALFUNCTION DURING ECMO SUPPORT IN WHICH THE PATIENT EXPERIENCED INADEQUATE BLOOD FLOW FOR AN EXTENDED PERIOD OF TIME AS REPORTED BY THE LOCAL COMPLAINT HANDING UNIT. IT IS WELL KNOWN THAT PATIENTS ON ECMO SUPPORT HAVE A SIGNIFICANTLY HIGH RISK FOR MORTALITY FOLLOWING OUT-OF-HOSPITAL CARDIAC ARRESTS WITH ECMO-ASSISTED CPR. ADDITIONALLY, CEREBRAL EDEMA IS FOUND TO BE ONE OF THE MOST SIGNIFICANT CONSEQUENCES LEADING TO DEATH FOR ECMO SUPPORTED PATIENTS. AS THE SOURCE OF THE MALFUNCTION OF THE OXYGENATOR REMAINS UNKNOWN, THE XLUNG KIT 230 CANNOT BE EXCLUDED AS A POTENTIAL SOURCE OR CONTRIBUTOR TO THIS PATIENT¿S ADVERSE EVENTS. PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE LOG DATA OF CONSOLE XEN0011 WAS PROVIDED BY THE USER FACILITY. WHEN SUPPORT WAS INITIATED ON (B)(6) 2025, THE PUMP SPEED WAS SET TO 7000 RPM RESULTING IN A BLOOD FLOW OF APPROXIMATELY 3 L/MIN. THE BLOOD FLOW WAS MAINTAINED AT 3 TO 4 L/MIN AT PUMP SPEED OF 6400 - 8500 RPM. THERE WERE NO ALARMS REGARDING THE PUMP DRIVE OR THE PUMP HEAD. ON (B)(6) AT 9:45 A.M., A BACKFLOW WAS DETECTED AS THE FLOW AND PRESSURE DECREASED. POWER CONSUMPTION DECREASED, INDICATING NO HYDRAULIC PUMP POWER AND THE DRIVE ROTATED ON ITS OWN WITHOUT RESISTANCE AND THE SPEED EXCEEDED 10,000 RPM, MEANING THAT THE SPEED CONTROL EXCEEDED NORMAL LIMITS SLIGHTLY DUE TO THE LACK OF FLUID LOAD. THE PUMP DRIVE STOPPED AT 9:52 A.M. ON (B)(6) AND THE CONSOLE WAS SHUT DOWN. THE LOG FILES SHOW NO FAILURE OR MALFUNCTION OF THE CONSOLE. THE DATA DOES NOT INDICATE ANY MALFUNCTION OF THE DRIVE OR PUMP HEAD.

Description of Event or Problem

ON 26/NOV/2025, FRESENIUS BECAME AWARE OF THIS CRITICALLY ILL MALE PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT UTILIZING THE XLUNG KIT 230 WHO EXPIRED FOLLOWING INADEQUATE BLOOD FLOW. THERE WAS AN INFERRED ALLEGATION THAT THIS EVENT WAS DUE TO THE PERFORMANCE OF THE XLUNG KIT 230 IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE XENIOS COMPLAINT HANDLING UNIT, IT WAS REPORTED THIS PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AT 14:00 (ALL REPORTED TIMES LOCAL) ON (B)(6) 2025 DUE TO AN UNEXPLAINED SUDDEN CARDIAC ARREST AND COMA, FOLLOWED BY ONSITE CARDIOPULMONARY RESUSCITATION (CPR) AND EMERGENCY TRANSFER TO THE HOSPITAL. UPON ADMISSION, THE PATIENT EXPERIENCED A RETURN OF SYSTEMIC CIRCULATION, AND VENO-ARTERIAL (VA) ECMO SUPPORT WAS INITIATED. THE PATIENT'S SYSTEMIC CIRCULATION HAD BEEN RESTORED, BUT DUE TO CIRCULATORY FAILURE, BLOOD PRESSURE COULD NOT BE MAINTAINED WITH HIGH-DOSE VASOPRESSORS. A PREEMPTIVE COMPUTED TOMOGRAPHY (CT) MEDICAL IMAGING SCAN PERFORMED AT 21:00 ON THE SAME DAY SHOWED NO SIGNIFICANT ABNORMALITIES ON NON-CONTRAST HEAD CT. ON (B)(6) 2025 AT 10:00, THE ECMO MACHINE UNEXPECTEDLY STOPPED PUMPING, AND AN ABNORMAL SOUND OCCURRED. BEFORE THIS EVENT, THE ROTATIONAL SPEED WAS 7,000 RPM. AFTER THE NOISE OCCURRED, THE PUMP NEARLY STOPPED AS THE PHYSICIAN INCREASED THE PUMP SPEED TO 10,000 RPM, WHICH PRODUCED AN INADEQUATE BLOOD FLOW RATE OF 0.6 L/MIN. THE SOURCE OF THE ABNORMAL NOISE AND DECREASED BLOOD FLOW RATE WAS UNKNOWN. AT 10:10, THE PATIENT EXPERIENCED A CARDIAC ARREST. BY 11:30, THE OXYGENATOR WAS SUCCESSFULLY REPLACED, RESULTING IN PATIENT BLOOD LOSS OF APPROXIMATELY 500 ML. VASCULAR CANNULAS WERE INSPECTED AT THE TIME OF KIT EXCHANGE, AND NO EMBOLI WERE NOTED. ECMO SUPPORT WAS RESTARTED WITH A BLOOD FLOW RATE OF 3.6 L/MIN AND A PUMP SPEED OF 7500 RPM. BY 11:31 ON THE SAME DAY, THE PATIENT'S BLOOD PRESSURE, OXYGEN SATURATION, AND HEART RATE WERE RESTORED TO EXPECTED VALUES. A FOLLOW-UP HEAD CT ON (B)(6) 2025 REVEALED GLOBAL CEREBRAL SWELLING, INDICATING THE HIGH LIKELIHOOD OF BRAIN DEATH. THE PATIENT¿S POTENTIAL BRAIN DEATH WAS DETERMINED TO BE DIRECTLY RELATED TO THE MALFUNCTION ON (B)(6) 2025 DUE TO THE PROLONGED TROUBLESHOOTING PROCESS AND THE EXTENDED DURATION OF THE PATIENT¿S CARDIAC ARREST. GIVEN ABNORMAL ELECTROENCEPHALOGRAM FINDINGS AND THE HIGH LIKELIHOOD OF BRAIN DEATH, THE FAMILY DECIDED TO WITHDRAW SUPPORT ON (B)(6) 2025, AND THE PATIENT EXPIRED FOLLOWING TERMINATION OF SUPPORT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.