XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR PRODUCT EVALUATION. THE OBSERVED LOW POST-MEMBRANE PAO2 PRIOR TO REPLACEMENT MAY INDICATE ALTERED MEMBRANE DIFFUSION PERFORMANCE; HOWEVER, SYSTEMIC OXYGENATION LIMITATIONS WERE LIKELY MULTIFACTORIAL (LOW CARDIAC OUTPUT, ANEMIA, ARDS SEVERITY). THE ANALYSIS IDENTIFIED THE VARIABILITY IN THE MAT FIBER SUPPLIED AS THE MOST PROBABLE ROOT CAUSE. NO IN-HOUSE PROCESS, MATERIAL, OR DESIGN FACTOR CONTRIBUTING SIGNIFICANTLY TO THE ISSUE COULD BE VERIFIED AS ROOT CAUSE.

Description of Event or Problem

A USER FACILITY REPORTED ON A PATIENT WHO RECEIVED VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT FOR SEVERE PNEUMONIA AND ACUTE RESPIRATORY DISTRESS SYNDROME. ECMO SUPPORT WAS INITIATED WITH THE XLUNG KIT 230 (BATCH NUMBER GSXD1410) AT 16:00 (ALL TIMES LOCAL) ON (B)(6) 2026, WITH A POST-MEMBRANE PARTIAL PRESSURE OF OXYGEN (PAO2) OF 86 MMHG AND A POST-MEMBRANE OXYGEN SATURATION (SAO2) OF 98% AT THE START OF TREATMENT. THE HOSPITAL ATTEMPTED TO INCREASE THE GAS FLOW RATE, YET NO IMPROVEMENT WAS OBSERVED. THE HOSPITAL CONFIRMED PROPER ECMO CONNECTIONS, RULING OUT ANY PROCEDURAL ERRORS. OXYGENATION REMAINED UNIMPROVED ON (B)(6) 2026. THE USERS THEN REPLACED THE OXYGENATOR WITH AN XLUNG KIT, BATCH NUMBER GSXE0513, AT 09:30 ON (B)(6). NO THROMBI WERE FOUND IN THE CIRCUIT OR PUMP HEAD ONCE REMOVED FROM THE PATIENT. FOLLOWING THE REPLACEMENT, THE POST-MEMBRANE PAO2 REACHED 374 MMHG AND THE POST-MEMBRANE SAO2 WAS 100%. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50 ML DURING THIS EVENT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

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 ON A PATIENT WHO RECEIVED VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT FOR SEVERE PNEUMONIA AND ACUTE RESPIRATORY DISTRESS SYNDROME. ECMO SUPPORT WAS INITIATED WITH THE XLUNG KIT 230 (BATCH NUMBER GSXD1410) AT 16:00 (ALL TIMES LOCAL) ON (B)(6) 2026, WITH A POST-MEMBRANE PARTIAL PRESSURE OF OXYGEN (PAO2) OF 86 MMHG AND A POST-MEMBRANE OXYGEN SATURATION (SAO2) OF 98% AT THE START OF TREATMENT. THE HOSPITAL ATTEMPTED TO INCREASE THE GAS FLOW RATE, YET NO IMPROVEMENT WAS OBSERVED. THE HOSPITAL CONFIRMED PROPER ECMO CONNECTIONS, RULING OUT ANY PROCEDURAL ERRORS. OXYGENATION REMAINED UNIMPROVED ON (B)(6) 2026. THE USERS THEN REPLACED THE OXYGENATOR WITH AN XLUNG KIT, BATCH NUMBER GSXE0513, AT 09:30 ON (B)(6). NO THROMBI WERE FOUND IN THE CIRCUIT OR PUMP HEAD ONCE REMOVED FROM THE PATIENT. FOLLOWING THE REPLACEMENT, THE POST-MEMBRANE PAO2 REACHED 374 MMHG AND THE POST-MEMBRANE SAO2 WAS 100%. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50 ML DURING THIS EVENT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.