XLUNG KIT 230

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 A PATIENT WAS PLACED ON VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2025 DUE TO SEVERE PNEUMONIA AND FURTHER LUNG INFECTION. ECMO SETTINGS INCLUDED A BLOOD FLOW RATE OF 4.3 L/MIN AND A SWEEP GAS OF 8 L/MIN WITH 100% FIO2. THROUGH LABORATORY TESTING, VENOUS OXYGENATION (PVO2) BEFORE THE MEMBRANE WAS 40 MMHG, AND ARTERIAL OXYGENATION (PAO2) AFTER THE MEMBRANE WAS 79 MMHG WITH AN OXYGEN SATURATION OF 95%. LABORATORY RESULTS TAKEN DIRECTLY FROM THE PATIENT PRESENTED A PAO2 OF 65 MMHG, A PVO2 OF 40 MMHG AND AN SAO2 OF 70%. THE PHYSICIAN DETERMINED THE PAO2 WAS LOW FOLLOWING THE BEGINNING OF TREATMENT. THE HOSPITAL USED HEPARIN FOR ANTICOAGULATION WHICH YIELDED AN APTT WAS 43.6S DURING SUPPORT. A LOCAL SALES COLLEAGUE DETERMINED THE CONNECTIONS WERE CORRECT. THE PATIENT HAD A TOTAL BLOOD LOSS OF APPROXIMATELY 800 ML DUE TO KIT EXCHANGE. THERE WAS NO INDICATION OF PATIENT INJURY RESULTING FROM SUBOPTIMAL OXYGENATION OR BLOOD LOSS. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A2, B5, D3, D4, D9, G1 NON-CONFORMITY WAS NOT OBSERVED DURING MANUFACTURING PROCESS. PERFORMANCE TEST FOR GAS EXCHANGE WAS WITHIN SPECIFICATIONS. FOUR SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE BATCH FSXG0113 PASSED ALL QUALITY CONTROLS AND ALL SPECIFICATIONS WERE MET. THREE UNUSED PRODUCTS OF BATCH FSXG0113 WERE EVALUATED. THEY ARRIVED WITHOUT ANY VISIBLE DEFECT. ALL THREE OXYGENATORS DEMONSTRATED OXYGEN TRANSFER PERFORMANCE WITHIN SPECIFICATION. THE CO2 TRANSFER DEVIATION IN TWO SAMPLES (1% AND 8%) LIKELY REFLECTS MEASUREMENT VARIABILITY AND IS NOT EXPECTED TO AFFECT OXYGEN TRANSFER EFFICIENCY. A DEFINITIVE CAUSE FOR THE REPORTED LOW PAO2 CANNOT BE DETERMINED. BASED ON THE PROVIDED DATA, THE ESTIMATED OXYGEN TRANSFER VALUES RANGE BETWEEN APPROXIMATELY 247 ML/MIN AND 257 ML/MIN. THESE CALCULATED NUMBERS ARE NOT EXTREMELY LOW BUT MAY BE LOWER THAN EXPECTED FOR AN ECMO OXYGENATOR UNDER THE OPERATING CONDITIONS PROVIDED. HOWEVER, EXPECTED PERFORMANCE CAN VARY DEPENDING ON CLINICAL FACTORS SUCH AS VENOUS SATURATION, HEMOGLOBIN CONCENTRATION, AND PATIENT-SPECIFIC METABOLIC DEMAND. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES.

Description of Event or Problem

A USER FACILITY REPORTED A PATIENT WAS PLACED ON VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2025 DUE TO SEVERE PNEUMONIA AND FURTHER LUNG INFECTION. ECMO SETTINGS INCLUDED A BLOOD FLOW RATE OF 4.3 L/MIN AND A SWEEP GAS OF 8 L/MIN WITH 100% FIO2. THROUGH LABORATORY TESTING, VENOUS OXYGENATION (PVO2) BEFORE THE MEMBRANE WAS 40 MMHG, AND ARTERIAL OXYGENATION (PAO2) AFTER THE MEMBRANE WAS 79 MMHG WITH AN OXYGEN SATURATION OF 95%. LABORATORY RESULTS TAKEN DIRECTLY FROM THE PATIENT PRESENTED A PAO2 OF 65 MMHG, A VENOUS OXYGENATION (PVO2) OF 40 MMHG AND A BLOOD OXYGEN SATURATION (SAO2) OF 70%. THE PHYSICIAN DETERMINED THE PAO2 WAS LOW FOLLOWING THE BEGINNING OF SUPPORT. THE HOSPITAL USED HEPARIN FOR ANTICOAGULATION WHICH YIELDED AN APTT WAS 43.6S DURING SUPPORT. A LOCAL SALES COLLEAGUE DETERMINED THE CONNECTIONS WERE CORRECT. THE PATIENT HAD A TOTAL BLOOD LOSS OF APPROXIMATELY 800 ML DUE TO KIT EXCHANGE. THERE WAS NO INDICATION OF PATIENT INJURY RESULTING FROM SUBOPTIMAL OXYGENATION OR BLOOD LOSS. A COMPANION SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.