InjuryQJZ

FRESENIUS NOVALUNG NOVALUNG DEVICE FOR ECMO

Received Jan 31, 2025 · Event occurred Nov 13, 2024

Report MW5165594 · MDR key 21298096

Device

Generic name

Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure

Manufacturer

Fresenius Medical Care/xenios Ag

Patient

72 YR · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NOVALUNG FROM FRESENIUS MEDICAL WAS USED ON A PATIENT ON VA ECMO (VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION). WHEN ON A SWEEP OF 2LPM AND 50% THE POST PO2 (PARTIAL PRESSURE OF OXYGEN) RESULT WAS 69 MM HG. THIS RESULTED IN NEEDING TO SWITCH OUT DEVICE 10 HOURS INTO MEDICAL SUPPORT.