Patient Problems
Death (1802); Pericardial Effusion (3271)
Event Date 04/27/2020
Event Type
Death
Manufacturer Narrative
The umbilical catheter is not available, it was discarded.The batch review confirms that the product are compliant.The user confirms that the position of the catheter is correct.This serious adverse event is not linked to the catheter.The chorioamnionitis and the initial state of health are the most likely origin of this clinical degradation.
Event Description
The serious adverse event occured (b)(6) 2020.A (b)(6) gestation infant born on (b)(6) 2020 in an amnionitis context.An umbilical venous catheter was inserted on the day of birth.The position of the catheter has been checked.During the night of (b)(6), a clinical degradation of the state of health were noticed.Pericardial and peritoneal effusion.Cardiac massage during 20 minutes.Baby died on (b)(6) 2020.