Customer reports that the device malfunctioned during use on a premature newborn baby.
The device was working but "has stopped reading well" due to a leakage.
On 1/8/2021 additional information states: the uac stopped reading well, so the line was inspected.
Blood was noted to be backing up into catheter so all clamps were checked and verified fluid was infusing.
The uac was flushed and noted there was a leak in the line where it connects to the hub.
The uac was clamped below the leak, but per md had to be left in until off the ecmo circuit, which wasn't cut away until the end of the shift.
This resulted in the loss of an arterial line for an ecmo trial and cut away, and left no drawable lines for gases resulting in pokes of a heparinized infant.
|