XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: SECTION A (PATIENT INFORMATION), B5 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 EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED LOW POST-OXYGENATOR ARTERIAL OXYGEN (PAO2) VALUES. PROVIDED PHOTOGRAPHIC EVIDENCE SHOWED A PAO2 OF 153 MMHG. THE CONSOLE AND PATIENT CIRCUIT WERE EXCHANGED WITH A COMPETITOR PRODUCT. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED LOW POST-OXYGENATOR ARTERIAL OXYGEN (PAO2) VALUES. PROVIDED PHOTOGRAPHIC EVIDENCE SHOWED A PAO2 OF 153 MMHG. UPON FOLLOW-UP, IT WAS REPORTED THAT INITIAL PAO2 VALUES WERE 246 MMHG AND REMAINED BETWEEN 200 MMHG TO 230 MMHG FOR APPROXIMATELY SIX DAYS OF SUPPORT. THE LOW PAO2 VALUE OF 153 MMHG FOLLOWED DAY 6 WHEN THE CONSOLE AND PATIENT CIRCUIT WERE EXCHANGED WITH A COMPETITOR PRODUCT. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3, H6 PLANT INVESTIGATION: NON-CONFORMITY RELATED TO THE REPORTED FAILURE WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS RELATED TO THIS EVENT HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED ON DECEMBER 19, 2025. THE OXYGENATOR WAS RINSED PRIOR TO SHIPPING. NO VISIBLE EXTERNAL DEFECTS WERE DETECTED. TESTING OF THE GAS EXCHANGE PERFORMANCE SHOWED AN OXYGEN TRANSFER RATE OF 48 ML/MIN (LIMIT: 36 ML/MIN). AND THE MEASURED TRANSFER RATE FOR CO2 WAS 138 ML/MIN (LIMIT 111 ML/MIN). THE MEASURED GAS EXCHANGE PERFORMANCE MET THE ACCEPTANCE CRITERIA. THE INITIAL POST-MEMBRANE PAO2 WAS NOT PARTICULARLY HIGH, BUT ALSO NOT CRITICALLY LOW. IN PRINCIPLE, THE CLINICAL SETTING OR THE PATIENT'S CONDITION MAY HAVE CONTRIBUTED TO THIS. AFTER 6 DAYS OF USE, A POST-MEMBRANE PAO2 OF 153 MMHG IS DESCRIBED AND, ON THIS BASIS, A NEW PRODUCT WAS USED, RESULTING IN BETTER POST-MEMBRANE VALUES. HOWEVER, THE PATIENT WAS DESCRIBED AS HAVING AN SAO2 OF 97% AND AN SVO2 OF 84%, WHICH INDICATED THAT THERE WAS NO CRITICAL OXYGENATION DISORDER IN THE PATIENT. EXAMINATION OF THE SAMPLE DID NOT REVEAL ANY DEFECT. THE PERFORMANCE TEST SHOWED THAT THE OXYGENATOR WAS WITHIN THE PRODUCT SPECIFICATION FOR GAS TRANSFER. A CAUSE FOR THE DESCRIBED LOW PAO2 LEVELS COULD NOT BE CONFIRMED.

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 DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE USER NOTICED LOW POST-OXYGENATOR ARTERIAL OXYGEN (PAO2) VALUES. PROVIDED PHOTOGRAPHIC EVIDENCE SHOWED A PAO2 OF 153 MMHG. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.