inforMED
MalfunctionFOS

CATHETER, UMBILICAL ARTERY

Received Oct 18, 2022 · Event occurred Sep 23, 2022

Report 15629324 · MDR key 15629324

Device

Generic name

Catheter, Umbilical Artery

Lot number

64135772

Product problems

  • Defective Device

Patient

10 DA · Male

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

Narrative

Description of Event or Problem

LINE CHANGE WAS DUE FOR UMBILICAL ARTERY CATHETER (UAC) FLUIDS, THE LINE WAS CHANGED AND HUNG AT 1:20 AM. BLOOD PRESSURES WERE APPROPRIATE AND LINE SEEMED TO BE WORKING FINE. THEN BLOOD PRESSURE MEANS WERE 66/63 AND THEN NOT READING. THE LINE WAS ASSESSED AND FLUSHED AND SEEMED TO BE BETTER. THE DIAPER CLOTH UNDER THE LINE WAS NOTED TO BE WET BUT MULTIPLE REGISTERED NURSES (RNS) COULD NOT FIGURE OUT WHERE THE WET FEELING WAS COMING FROM. LINE FLUSHED AGAIN AND NO LEAKING TO BE NOTED. LINE CHECKED AGAIN AT 0400 BECAUSE IT WAS NOT WORKING AGAIN AND LEAKING NOTED FROM THE TUBING (NOT AT A LUER LOCK CONNECTION SITE). REGISTERED NURSE CALLED PHARMACY AND ORDERED NEW UAC FLUIDS. LINE TUBING WAS THEN CHANGED AND MALFUNCTIONING TUBING SAVED.