XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING ONGOING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE USER WANTED TO TRANSFER THE PATIENT TO A NEW ECMO KIT BEFORE THEY UNDERWENT A THORACIC SURGICAL PROCEDURE. THE PATIENT WAS SUPPORTED WITH A CARDIOHELP DEVICE (NOT A FRESENIUS/XENIOS PRODUCT) AND WAS SWITCHED TO THE NOVALUNG CONSOLE WITH XLUNG KIT 230 AT AROUND 11:40 (LOCAL TIME). INITIALLY, THE XLUNG KIT 230 COULD ONLY ACHIEVE A POST-OXYGENATOR BLOOD GAS OF 90 MMHG WHICH WAS LESS THAN THE 360 MMHG FOLLOWING PROLONGED SUPPORT WITH THE CARDIOHELP. THEREFORE, THE PATIENT WAS TRANSITIONED BACK TO THE CARDIOHELP AFTER APPROXIMATELY 30 MINUTES. ALSO, THE USER STATED THAT IT WAS IMPOSSIBLE TO ACHIEVE A HIGHER BLOOD FLOW THAN 4.2 L/MIN WHILE THE CARDIOHELP WAS RUNNING AT ABOUT 6 L/MIN AND THAT THE PUMP HEAD WAS VIBRATING LOUDLY WHILE TRYING TO ACHIEVE HIGHER BLOOD FLOW. THERE WAS NO PATIENT SERIOUS INJURY RESULTING. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9. 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 DURING ONGOING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE USER WANTED TO TRANSFER THE PATIENT TO A NEW ECMO KIT BEFORE THEY UNDERWENT A PROCEDURE. THE PATIENT WAS SUPPORTED WITH A CARDIOHELP DEVICE (NOT A FRESENIUS/XENIOS PRODUCT) AND WAS SWITCHED TO THE NOVALUNG CONSOLE WITH XLUNG KIT 230 AT AROUND 11:40 (LOCAL TIME). INITIALLY, THE XLUNG KIT 230 COULD ONLY ACHIEVE A POST-OXYGENATOR BLOOD GAS OF 90 MMHG WHICH WAS LESS THAN THE 360 MMHG FOLLOWING PROLONGED SUPPORT WITH THE CARDIOHELP. THEREFORE, THE PATIENT WAS TRANSITIONED BACK TO THE CARDIOHELP AFTER APPROXIMATELY 30 MINUTES. ALSO, THE USER STATED THAT IT WAS IMPOSSIBLE TO ACHIEVE A HIGHER BLOOD FLOW THAN 4.2 L/MIN WHILE THE CARDIOHELP WAS RUNNING AT ABOUT 6 L/MIN AND THAT THE PUMP HEAD WAS VIBRATING LOUDLY WHILE TRYING TO ACHIEVE HIGHER BLOOD FLOW. THERE WAS NO PATIENT SERIOUS INJURY RESULTING. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, H3, H4 PLANT INVESTIGATION: A REVIEW OF THE BATCH DOCUMENTATION REVEALED NO NONCONFORMITIES DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON MARCH 12, 2026. PORTIONS OF THE XLUNG KIT, INCLUDING THE OXYGENATOR WITH PARTIAL TUBING, THE INTEGRATED PRESSURE SENSOR OF THE P2 PORT AND THE PUMP HEAD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE SAMPLE HAD BEEN RINSED PRIOR TO SHIPPING. NO VISIBLE EXTERNAL DEFECTS WERE DETECTED. SOME RESIDUES OF RINSING FLUID MIXED WITH BLOOD WERE VISIBLE IN THE GAS EXCHANGER THAT WERE RINSED AND REMOVED. TESTING THE GAS EXCHANGE PERFORMANCE SHOWED THAT THE OXYGEN TRANSFER RATE WAS 42 ML/MIN (LIMIT: 36 ML/MIN) AND THE MEASURED TRANSFER RATE FOR CARBON DIOXIDE WAS 117 ML/MIN (LIMIT 111 ML/MIN). IT WAS DETERMINED THAT THE MEASURED GAS EXCHANGE PERFORMANCE MET THE ACCEPTANCE CRITERIA. THE SAMPLE WAS THEN CONNECTED TO A PRIMING SET, AND INTEGRATED PRESSURE SENSORS WERE CONNECTED UPSTREAM OF THE PUMP HEAD AND DOWNSTREAM OF THE OXYGENATOR. NO ISSUES WERE OBSERVED DURING FUNCTIONAL TESTING OF UP TO 10,000 RPMS. NO MALFUNCTION OR ABNORMAL NOISE OF THE PUMP HEAD WAS DETECTED. AS THE PERFORMANCE TEST SHOWED THAT THE GAS TRANSFER RATE OF THE OXYGENATOR WAS WITHIN SPECIFICATION, A DEFINITIVE CAUSE FOR THE REPORTED LOW OXYGEN LEVELS COULD NOT BE DETERMINED. ADDITIONALLY, FUNCTIONAL TESTING OF THE PUMP HEAD REVEALED NO MALFUNCTION OR ABNORMAL NOISE.

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING ONGOING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE USER WANTED TO TRANSFER THE PATIENT TO A NEW ECMO KIT BEFORE THEY UNDERWENT A THORACIC SURGICAL PROCEDURE. THE PATIENT WAS SUPPORTED WITH A CARDIOHELP DEVICE (NOT A FRESENIUS/XENIOS PRODUCT) AND WAS SWITCHED TO THE NOVALUNG CONSOLE WITH XLUNG KIT 230 AT AROUND 11:40 (LOCAL TIME). INITIALLY, THE XLUNG KIT 230 COULD ONLY ACHIEVE A POST-OXYGENATOR BLOOD GAS OF 90 MMHG WHICH WAS LESS THAN THE 360 MMHG FOLLOWING PROLONGED SUPPORT WITH THE CARDIOHELP. THEREFORE, THE PATIENT WAS TRANSITIONED BACK TO THE CARDIOHELP AFTER APPROXIMATELY 30 MINUTES. ALSO, THE USER STATED THAT IT WAS IMPOSSIBLE TO ACHIEVE A HIGHER BLOOD FLOW THAN 4.2 L/MIN WHILE THE CARDIOHELP WAS RUNNING AT ABOUT 6 L/MIN AND THAT THE PUMP HEAD WAS VIBRATING LOUDLY WHILE TRYING TO ACHIEVE HIGHER BLOOD FLOW. THERE WAS NO PATIENT SERIOUS INJURY RESULTING. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION.