Novalung console (Linux Board)

Description of Event or Problem

A user facility reported that during a recent case involving a patient on extracorporeal membrane oxygenation support utilizing the the Xenios 2.0 and the NUK SCS kit, it was necessary to perform cardioversion. The cardioversion made it impossible to continue with pulsatile support, and the console was unable to detect the R-wave due to an extreme amount of noise on the electrocardiogram. The noise disappeared in battery mode. The patient was switched to a back up pump drive, and following a full system restart, everything returned to normal and pulsatility could be reestablished. There was no specified patient serious injury. The complaint sample was not available for product evaluation.

Additional Manufacturer Narrative

The plant investigation is in process. A supplemental MDR will be submitted upon completion of this activity.