inforMED
MalfunctionFPB

MEDEX

Received Dec 6, 2023 · Event occurred Aug 29, 2023

Report 18273815 · MDR key 18273815

Device

Generic name

Filter, Infusion Line

Model number

MX448HFB

Lot number

UNKNOWN

Patient

Unknown

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

Narrative

Description of Event or Problem

INFANT HAS A UAC (UMBILICAL ARTERY CATHETER) AND UVC (UMBILICAL VENOUS CATHETER). UVC WITH TPN/IL RUNNING. UPON VISUAL INSPECTION DURING FIRST CARE TIME, YELLOW FLUID NOTED ON THE SHEETS UNDERNEATH THE TRI-FUSE AREA. PROVIDER NOTIFIED ABOUT LEAKING TUBING/CONNECTION. PADS PLACED UNDER LINES, FLUID APPARENTLY LEAKING FROM CONNECTION BETWEEN TPN FILTER AND ANTI-SIPHON VALVE. TPN/IL TAKEN DOWN AND NEW CLEAR FLUID HUNG. TUBING RETRIEVED FROM CLINICAL SITE AND EMAIL SENT TO MANUFACTURER REP. MANUFACTURER RESPONSE FOR IV TUBING, (BRAND NOT PROVIDED) (PER SITE REPORTER) EMAILED MFG REP ON [REDACTED DATE].