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 EXTRACORPOREAL MEMBRANE OXYGENATION WITH THE XLUNG KIT 230 ON SATURDAY, (B)(6) 2025. AFTER THE FIRST BLOOD GAS ANALYSIS, A NOTORIOUS LACK OF OXYGENATION WAS DETECTED BY THE KIT (PO2 LESS THAN 150 MMHG). ON MONDAY, AFTER BLOOD GAS ANALYSIS, PO2 WAS LESS THAN 80 MMHG, AND IT WAS DECIDED TO CHANGE THE SYSTEM FOR A NEW XLUNG KIT 230 (SAME LOT AS THE PREVIOUS FSXH0506). THE SAME RESULTS WERE NOTED (PO2 LESS THAN 150 MMHG). THE PRACTITIONER DECIDED TO REMOVE IT IMMEDIATELY AND PUT IN A COMPETITOR'S SYSTEM (CARDIOHELP), WHICH WORKED CORRECTLY FROM THE BEGINNING (PO2 GREATER THAN 300 MMHG). THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D3, D4, G1, H6. PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE AFFECTED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION AND A DEFINITIVE CAUSE FOR THE INADEQUATE OXYGENATION COULD NOT BE DETERMINED. THE REPORTED POST-OXYGENATOR ARTERIAL OXYGEN AND SATURATION VALUES SUGGEST SUBOPTIMAL OXYGENATOR PERFORMANCE OR REDUCED MEMBRANE EFFICIENCY. BASED ON THE DATA PROVIDED, THE OXYGEN TRANSFER (APPROXIMATELY 241 ML/MIN) WAS RELATIVELY LOW DESPITE THE FULL FRACTION OF INSPIRED OXYGEN, APPROPRIATE BLOOD AND GAS FLOWS AND THE ABSENCE OF ANY KNOWN MECHANICAL ISSUES. A FAILURE IN THE GAS EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL OR FURTHER PROCESSING DURING THE MANUFACTURING OF THE OXYGENATOR. ADDITIONALLY, THE PERFORMANCE OF THE GAS EXCHANGER IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION (ACT, APTT), BLOOD AND SWEEP GAS FLOW AND FRACTION OF INSPIRED OXYGEN. CLOTTING OF THE OXYGENATOR CAN NEGATIVELY IMPACT GAS EXCHANGE. ADDITIONALLY, HIGH BLOOD LEVELS OF FATS (HIGH SERUM LIPID LEVELS, E.G. AS A RESULT OF INTRAVENOUS NUTRITION [WITH LIPIDS] OR SEDATION WITH PROPOFOL) OR HIGH FIBRINOGEN CAN LEAD TO SECONDARY MEMBRANE FORMATION IN THE OXYGENATOR WHICH MAY RESULT IN IMPAIRED GAS EXCHANGE. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES. THE EVALUATION OF THESE CASES, AS WELL AS FURTHER INVESTIGATIONS AND THE EXAMINATION OF POSSIBLE CAUSES FOR REDUCED GAS EXCHANGE PERFORMANCE ARE CARRIED OUT WITHIN OUR QUALITY MANAGEMENT SYSTEM.

Description of Event or Problem

A USER FACILITY REPORTED A PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION WITH THE XLUNG KIT 230 ON (B)(6) 2025 FOLLOWING A BILATERAL PNEUMONIA DIAGNOSIS. AFTER THE FIRST BLOOD GAS ANALYSIS, A NOTORIOUS LACK OF OXYGENATION WAS DETECTED BY THE KIT (ARTERIAL OXYGEN LESS THAN 150 MMHG). THE PATIENT HAD NO PREEXISTING DISEASE OR CONDITIONS APART FROM THE INFECTION. COAGULATION AND LIPID LEVELS WERE NORMAL. HEPARIN WAS USED FOR ANTICOAGULATION WITH AN APTT OF 55-58 SECONDS. NO CLOTS WERE OBSERVED, AND DELTA PRESSURES (P2-P3) REMAINED STABLE WITH NO INCREASE. ON MONDAY, AFTER BLOOD GAS ANALYSIS, ARTERIAL OXYGEN WAS LESS THAN 80 MMHG, AND IT WAS DECIDED TO CHANGE THE SYSTEM FOR A NEW XLUNG KIT 230 (SAME LOT AS THE PREVIOUS FSXH0506). THE SAME RESULTS WERE NOTED (ARTERIAL OXYGEN LESS THAN 150 MMHG). THE PRACTITIONER DECIDED TO REMOVE IT IMMEDIATELY AND PUT IN A COMPETITOR'S SYSTEM (CARDIOHELP), WHICH WORKED CORRECTLY FROM THE BEGINNING (PO2 GREATER THAN 300 MMHG). THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.