NOVALUNG SYSTEM
Received Jan 31, 2025 · Event occurred Nov 22, 2024
Report MW5165590 · MDR key 21298039
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Fresenius / Xenios AgPatient
70 YR · Male
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Description of Event or Problem
FRESENIUS NOVALUNG AT 3 HOURS INTO VA ECMO RUN POST OXYGENATOR PAO2 WAS 77 MMHG ON 60% FIO2. HAD TO REDRAW ON 100% FIO2 WHICH SHOWED A PAO2 OF 372. BURPING CIRCUIT OVERNIGHT EVERY 1 HOUR AND DRAWING POST OXYGENATOR ABGS EVERY 2 HOURS SHOWED THE POST-OXYGENATOR PAO2 CONTINUED TO BE VOLATILE AND BOTH VERY HIGH AND QUITE LOW AT TIMES AS LOW AS 65 MM HG. OXYGENATOR ALSO SHOWING AREAS OF WHITE FIBERS, WHERE IT APPEARS THE FLOW OF BLOOD DOES NOT SEEM TO BE PASSING. WHEN COMPARED TO OTHER DEVICES THIS IS EXTREMELY LOW. WE STRIVE TO DELIVER A POST PO2 OF 100-200 MM OF HG, WITH THE HOPE OUR PATIENTS PAO2 WILL BE 80-100 MM OF HG. THERE IS AN INHERENT RISK OF USING THIS DEVICE ESPECIALLY AFTER ONLY 3 HOURS OF USE. CHANGES IN OUR PRACTICE WERE MADE AND MANY LABS WERE DRAWN TO ENSURE PROPER CARE OF A CRITICALLY ILL PATIENT.