inforMED
MalfunctionFIP

WRO 300H

Received Feb 3, 2025 · Event occurred Dec 10, 2024

Report 21294970 · MDR key 21294970

Device

Generic name

Subsystem, Water Purification

Catalog number

107365

Lot number

0100817492020832

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

PORTABLE REVERSE OSMOSIS (RO) HAS BEEN OUT OF SERVICE FOR OVER 6 MONTHS. DESPITE REPEATED REQUESTS FROM THE VENDOR AND MONTHS OF WAITING FOR REPAIRS, A TECHNICIAN FINALLY CAME YESTERDAY TO FIX THE MACHINE. THE TECHNICIAN ADVISED RUNNING THE RO ON A HEAT CYCLE BEFORE PUTTING IT BACK INTO USE. FOLLOWING THIS RECOMMENDATION, THE PORTABLE RO WAS PLACED IN THE EQUIPMENT ROOM AND LEFT RUNNING ON HEAT. HOWEVER, A NURSE LEAVING THE DIALYSIS UNIT NOTICED SMOKE COMING FROM THE EQUIPMENT ROOM. THEY FOUND THE PORTABLE RO EMITTING SMOKE. THE DEVICE WAS IMMEDIATELY UNPLUGGED TO PREVENT A POTENTIAL FIRE. THE RO HAS SINCE BEEN REMOVED TO SERVICE, LABELED AS "DO NOT USE," AND A TICKET HAS BEEN SUBMITTED TO BIOMED FOR FURTHER INVESTIGATION. IT IS WORTH NOTING THAT THIS INCIDENT APPEARS TO BE RELATED TO THE SAME PROBLEM THAT THE RO EXPERIENCED PREVIOUSLY. MANUFACTURER RESPONSE FOR SUBSYSTEM, WATER PURIFICATION, WRO 300H (PER SITE REPORTER). SERVICED BY THE FACTORY PERSON AND AFTER REPAIR BEFORE USE TO THE PATIENT CAUGHT ON FIRE.