inforMED
MalfunctionFPB

1.2 MICRON FILTER

Received Jul 7, 2023 · Event occurred Jun 5, 2023

Report 17277386 · MDR key 17277386

Device

Generic name

Filter, Infusion Line

Manufacturer

Pall Corporation

Lot number

GR00014527

Product problems

  • Backflow
  • Crack
  • Fluid/Blood Leak

Patient

5840 DA · Male

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

Narrative

Description of Event or Problem

PATIENT WAS RUNNING TOTAL PARENTERAL NUTRITION (TPN) AND LIPIDS THROUGH A CENTRAL LINE. PATIENT NOTICED BED SHEET WAS WET DUE TO LEAK IN 1.2 MICRON FILTER THAT LIPIDS WAS RUNNING THROUGH. PATIENT'S MOTHER NOTICED THAT TPN WAS BACKFLOWING INTO FILTER AND LEAKING OUT WHILE LIPIDS WERE STOPPED. REGISTERED NURSE (RN) CONFIRMED CRACK IN 1.2 MICRON FILTER. PATIENT'S MOTHER STATES THIS IS THE THIRD TIME THIS HAS HAPPENED SINCE THEY HAVE BEEN ADMITTED.