XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A3, B5, D4, D9, H3 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RETURNED BUT ARRIVED FILLED WITH BLOOD AND CLOTS IN THE OXYGENATOR; THEREFORE, THE SAMPLE COULD NOT BE TESTED FOR GAS EXCHANGE PERFORMANCE. THE CAUSE FOR LOW POST-OXYGENATOR PARTIAL PRESSURE OF OXYGEN (PAO2) OR LOW OXYGENATOR PERFORMANCE CAN BE PRODUCT AS WELL AS APPLICATION/PATIENT RELATED. DUE TO THE INCREASED NUMBER OF COMPLAINTS DESCRIBING A LOW POST-OXYGENATOR PAO2 VALUE, A QUALITY EVENT WAS OPENED FOR FURTHER INVESTIGATION. WHILE THE SPECIFIC CAUSE FOR THE REPORTED PERFORMANCE ISSUE COULD NOT BE CONCLUSIVELY DETERMINED, THE CLINICAL AND LABORATORY CONTEXT SUGGESTS THAT PATIENT-RELATED FACTORS, INCLUDING INFLAMMATION AND HYPERCOAGULABILITY, LIKELY PLAYED A ROLE. LABORATORY PARAMETERS INDICATED A PROTHROMBOTIC AND HIGHLY INFLAMMATORY STATE (ELEVATED FIBRINOGEN, THROMBOCYTES, AND INFLAMMATORY MARKERS), WHICH CAN INCREASE THE RISK OF EARLY OXYGENATOR CLOTTING AND PERFORMANCE DEGRADATION. THE PATIENT WAS ALSO RECEIVING PROPOFOL WHICH IS KNOWN TO HAVE IMPLICATIONS FOR LIPID METABOLISM AND MAY CONTRIBUTE TO OXYGENATOR PERFORMANCE ISSUES IN SOME CASES. HOWEVER, IN THIS INSTANCE, TRIGLYCERIDE LEVELS WERE REPORTED TO BE WITHIN NORMAL RANGE.

Description of Event or Problem

A USER FACILITY REPORTED UNSATISFYING OXYGENATOR PERFORMANCE SHORTLY AFTER THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. UPON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT'S POST-OXYGENATOR ARTERIAL OXYGEN WAS BETWEEN 165 MMHG AND 240 MMHG FOR 14 HOURS. AFTER 36 HOURS, THE PATIENT'S ARTERIAL OXYGEN WAS AROUND 330 MMHG AND REMAINED AT THIS LEVEL. ECMO SUPPORT WAS CONTINUED WITH THE SECOND KIT FOR THREE DAYS UNTIL SUPPORT WAS DISCONTINUED. THE COMPLAINT SAMPLE WAS RETURNED TO XENIOS 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 UNSATISFYING OXYGENATOR PERFORMANCE SHORTLY AFTER THE START OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.