BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRO 300H

    MDR report key: 21294970 · Received February 3, 2025

    Report

    Report Number
    21294970
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    December 10, 2024
    Report Date
    December 11, 2024
    Manufacturer
    EVOQUA WATER TECHNOLOGIES, LLC
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359457 WRO 300H SUBSYSTEM, WATER PURIFICATION FIP EVOQUA WATER TECHNOLOGIES, LLC RO,WRO 300 H,115V~,60HZ 0100817492020832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown