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 OXYGENATION WAS INADEQUATE DURING VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION. A BLOOD GAS ANALYSIS OF POST-MEMBRANE ARTERIAL OXYGEN WAS 62.2 MMHG ON (B)(6)2025 AT 18:05 (LOCAL). ECMO SETTINGS INCLUDED A BLOOD FLOW RATE OF 8L/MIN WITH AN FIO2 OF 100%. THE PHYSICIAN DECIDED TO EXCHANGE THE CONSOLE AND OXYGENATOR TO COMPETITOR PRODUCTS, RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THERE WAS NO RESULTING PATIENT INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. THE PERFORMANCE TEST FOR GAS EXCHANGE WAS WITHIN SPECIFICATION. THREE OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER; HOWEVER, THE OBSERVED FAILURE PATTERNS ARE NOT RELATED TO THIS COMPLAINT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. AS A PHYSICAL EVALUATION COULD NOT BE CARRIED OUT, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. THE CAUSE OF LOW POST-OXYGENATOR PARTIAL OXYGEN PRESSURE (PAO2) OR LOW OXYGENATOR PERFORMANCE CAN BE PRODUCT AS WELL AS APPLICATION/PATIENT RELATED. A FAILURE IN THE GAS EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL PROCESSING DURING THE MANUFACTURING OF THE OXYGENATOR. ADDITIONALLY, THE PERFORMANCE OF THE GAS EXCHANGER IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION (ACT, APTT), BLOOD FLOW, SWEEP GAS FLOW AND/OR 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 I.V.-NUTRITION WITH LIPIDS OR LIPID-BASED SEDATION WITH PROPOFOL) OR HIGH FIBRINOGEN CAN LEAD TO SECONDARY MEMBRANE FORMATION IN THE OXYGENATOR WHICH MAY RESULT IN IMPAIRED GAS EXCHANGE. DUE TO AN INCREASED NUMBER OF COMPLAINTS DESCRIBING A LOW POST-OXYGENATOR PAO2 VALUE, A QUALITY EVENT WAS OPENED FOR FURTHER INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED OXYGENATION WAS INADEQUATE DURING VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION FOR A PATIENT DIAGNOSED WITH SEVERE PNEUMONIA AND PSITTACOSIS. A BLOOD GAS ANALYSIS OF POST-MEMBRANE ARTERIAL OXYGEN WAS 62.2 MMHG ON (B)(6) 2025 AT 18:05 (LOCAL). ECMO SETTINGS INCLUDED A BLOOD FLOW RATE OF 8L/MIN WITH AN FIO2 OF 100%. THE PHYSICIAN DECIDED TO EXCHANGE THE CONSOLE AND OXYGENATOR TO COMPETITOR PRODUCTS, RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION. UPON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO RESULTING SERIOUS INJURY.