NOVALUNG CONSOLE (LINUX BOARD)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED FROM FOLLOW-UP: B5, D9 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 THAT A PATIENT WAS PLACED ON NOVALUNG FOLLOWING BLEEDING DURING A CARDIAC PROCEDURE AND UNABLE TO ACHIEVE CIRCUIT FLOWS OF HIGHER THAN 1.5 L/MIN. THIS PATIENT WAS IN THE OPERATING ROOM AND WEANED FROM CARDIAC BYPASS FOLLOWING RIGHT HEART FAILURE AND A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE. THE PATIENT WAS PLACED ON NOVALUNG FOR PERIPHERAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) WITH A 25 FR ACCESS CANNULA AND 20 FR RETURN CANNULA. FLOWS WERE INITIATED AND UNABLE TO ACHIEVE HIGHER THAN 1.5 L/MIN AT 7800 RPM. PATIENT WAS FLUID RESUSCITATED WITH NO CHANGE. UPON FOLLOW-UP, IT WAS REPORTED THAT BLOOD FLOW ISSUES WERE ATTRIBUTED TO BLEEDING THAT BEGAN PRIOR TO ECMO SUPPORT. THE PUMP POWER REMAINED CONSISTENT INDICATING THAT ACCESS INSUFFICIENCY WAS THE PROBLEM. THE PATIENT TRANSITIONED TO A COMPETITOR ECMO DEVICE WITH A NEW CIRCUIT AND BLOOD FLOWS WERE 3.5 LPM. THERE WAS NO INDICATION OF RESULTING PATIENT INJURY. THE PATIENT CIRCUIT WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED FROM FOLLOW-UP: B5, D4 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS AND FINAL INSPECTION RESULTED IN CONFORMITY. NO OTHER COMPLAINTS HAVE BEEN REPORTED ABOUT THIS DEVICE, XEN0043. MACHINE FILES WERE RECEIVED AND REVIEWED FROM THE DEVICE. THE PATIENT WAS BLEEDING DURING AND AFTER SURGERY. VOLUME RESUSCITATION WAS ONGOING. FLOW WAS APPROPRIATE UNTIL P1 PRESSURES BECAME INCREASINGLY NEGATIVE AND WHEN PRESSURES WERE MORE NEGATIVE THAN -110 MMHG, FLOW WAS AFFECTED. THERE WERE PERIODS WHERE FLOW WAS -150 MMHG AND DOWN TO -280 MMHG WITH VERY LITTLE SUBSEQUENT FLOW. P2 AND P3 PRESSURES FELL IN CONJUNCTION AND PUMP POWER REMAINED CONSISTENT, INDICATING PATIENT ACCESS INSUFFICIENCY WAS THE PROBLEM. BASED ON THE DATA, NO ABNORMAL BEHAVIOR OF THE DEVICE CAN BE DETECTED. AFTER THE PRESUMED START OF THERAPY AT AROUND 02:30 (LOCAL), THE SYSTEM RAN WITH A FLOW OF BETWEEN 3 AND 4 L/MIN. IT WAS NOT UNTIL 04:15 (LOCAL) THAT THE FLOW DROPPED TO THE DESCRIBED 1.5 L/MIN AT THE SAME OR EVEN HIGHER SPEED, BUT AT THE SAME TIME THE P1 ALSO BECAME MORE NEGATIVE. THE P1 CORRELATES WITH THE FLOW RATE. THE POWER ALSO CORRELATES WITH THE FLOW AND SPEED OVER THE ENTIRE COURSE AND GIVES NO INDICATION OF A MALFUNCTION. THE DECREASE IN FLOW RATE IN CONJUNCTION WITH THE SHARP DROP IN PRESSURE AT P1 INDICATES THAT THE ACCESS CANNULA IS BEING ASPIRATED.

Description of Event or Problem

A USER FACILITY REPORTED THAT A PATIENT WAS PLACED ON NOVALUNG FOLLOWING BLEEDING DURING A CARDIAC PROCEDURE AND UNABLE TO ACHIEVE CIRCUIT FLOWS OF HIGHER THAN 1.5 L/MIN. THIS PATIENT WAS IN THE OPERATING ROOM AND WEANED FROM CARDIAC BYPASS FOLLOWING RIGHT HEART FAILURE AND A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE. THE PATIENT WAS PLACED ON NOVALUNG FOR PERIPHERAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) WITH A 25 FR ACCESS CANNULA AND 20 FR RETURN CANNULA. FLOWS WERE INITIATED AND UNABLE TO ACHIEVE HIGHER THAN 1.5 L/MIN AT 7800 RPM. PATIENT WAS FLUID RESUSCITATED WITH NO CHANGE. UPON FOLLOW-UP, IT WAS REPORTED THAT BLOOD FLOW ISSUES WERE ATTRIBUTED TO BLEEDING THAT BEGAN PRIOR TO ECMO SUPPORT. THE PUMP POWER REMAINED CONSISTENT INDICATING THAT ACCESS INSUFFICIENCY WAS THE PROBLEM. THE PATIENT TRANSITIONED TO A COMPETITOR ECMO DEVICE WITH A NEW CIRCUIT AND BLOOD FLOWS WERE 3.5 LPM. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY. THE PATIENT CIRCUIT WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION; HOWEVER, MACHINE FILE WERE RECEIVED BY XENIOS FOR DEVICE EVALUATION.

Description of Event or Problem

A USER FACILITY REPORTED THAT A PATIENT WAS PLACED ON NOVALUNG AND UNABLE TO ACHIEVE CIRCUIT FLOWS OF HIGHER THAN 1.5 L/MIN. THIS PATIENT WAS IN THE OPERATING ROOM AND WEANED FROM CARDIAC BYPASS FOLLOWING RIGHT HEART FAILURE. THE PATIENT WAS PLACED ON NOVALUNG FOR PERIPHERAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) WITH A 25 FR ACCESS CANNULA AND 20 FR RETURN CANNULA. FLOWS WERE INITIATED AND UNABLE TO ACHIEVE HIGHER THAN 1.5 L/MIN AT 7800 RPM. PATIENT WAS FLUID RESUSCITATED WITH NO CHANGE. TROUBLESHOOTING WAS CONDUCTED AND UNABLE TO LOCATE PROBLEM PREVENTING ADEQUATE BLOOD FLOWS. PATIENT TRANSITIONED TO A DIFFERENT ECMO DEVICE WITH NEW CIRCUIT AND BLOOD FLOWS WERE IMMEDIATELY 3.5 LPM. THERE WAS NO INDICATION OF RESULTING PATIENT INJURY. THE PATIENT CIRCUIT WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.