inforMED
InjuryKSE

FOLLETT MEDICATION REFRIGERATOR

Received Jan 25, 2019 · Event occurred Dec 12, 2018

Report MW5083414 · MDR key 8281570

Device

Generic name

Refrigerator, Freezer, Blood Storage

Manufacturer

Follett Llc

Model number

REF 20/25

Product problems

  • Microbial Contamination of Device

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

MULTIPLE MEDICATION REFRIGERATORS FROM FOLLETT (MANUFACTURER) WERE IDENTIFIED AS HAVING MOLD GROWTH INSIDE ON BINS AND RACKS. CLEANING AND DISINFECTION REMOVED THE VISIBLE MOLD, BUT A WEEK LATER SMALL AMOUNTS OF GROWTH HAVE RETURNED. ONE REFRIGERATOR WAS SEQUESTERED AND DISASSEMBLED DOWN TO THE EVAPORATOR WHERE THE SAME GROWTH WAS VISUALLY IDENTIFIED. AN UNUSUAL MOLD GROWTH HAS BEEN IDENTIFIED IN SEVERAL FOLLETT MEDICATION REFRIGERATORS. THE PHARMACY, INFECTION PREVENTION, BIOMEDICAL ENGINEERING, SAFETY, FACILITIES HAVE BEEN WORKING CLOSELY IN COLLABORATION WITH THE FOLLETT REFRIGERATOR MANUFACTURER OVER THE PAST WEEKS TO IDENTIFY AND CORRECT THOSE ISSUES. WE ARE ALSO IN CONSULTATION WITH OUR PUBLIC HEALTH COLLEAGUES AT THE STATE LEVEL (WHO HAVE REACHED OUT TO CDC) WHO ARE IN AGREEMENT WITH OUR APPROACH PENDING ANY FURTHER RECOMMENDATIONS. IT'S IMPORTANT TO NOTE THAT WE HAVE NOT SEEN ANY CASES OF FUNGAL INFECTION IN OUR PATIENTS, RELATED TO THIS ISSUE. OUR SHORT TERM PLAN IS TO INSPECT AND CLEAN ANY AFFECTED REFRIGERATORS. OUR LONG TERM PLAN IS TO REPLACE THE MODULE THAT HOUSES THE CONDENSATION COIL/EVAPORATOR UNIT IN AFFECTED REFRIGERATORS AS WE DO NOT HAVE A WAY OF ASSURING A THROUGH AND COMPLETE CLEANING OF THOSE UNITS. THE REMEDIATION PLAN IS COMPLEX AND REQUIRES US TO SWAP OUT THE AFFECTED REFRIGERATORS, CLEAN AND DISINFECT MEDICATION BINS AND THE UNITS THEMSELVES. EIGHT REFRIGERATORS ARE CONFIRMED FOR HYALODENDRON. ANOTHER 30+ CULTURE SWABS ARE PENDING. IT IS NOT KNOWN WHETHER THE FUNGUS WAS INTRODUCED TO THE REFRIGERATORS AT OUR FACILITY, OR AT THE TIME OF MANUFACTURE. SERIAL NUMBERS INCLUDE: (B)(4).