WRO 300H
Received Feb 3, 2025 · Event occurred Dec 10, 2024
Report 21294970 · MDR key 21294970
Device
Generic name
Subsystem, Water Purification
Manufacturer
Evoqua Water Technologies, LlcModel number
RO,WRO 300 H,115V~,60HZCatalog 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.