BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRO 300H

    MDR report key: 14436562 · Received May 19, 2022

    Report

    Report Number
    14436562
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 9, 2022
    Manufacturer
    MAR COR PURIFICATION, INC.
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS STARTED ON DIALYSIS IN THE ICU, SHORTLY AFTER STARTING THE RO STARTED TO ALARM, "CONDUCTIVITY ALARM". IT WOULD SILENCE AND THE PATIENT CONTINUED TO RUN WITHOUT AN ISSUE WHILE THE TECH BROUGHT UP A NEW RO AND THE PATIENT WAS RINSED BACK AND HER MACHINE WAS HOOKED UP TO THE NEW RO AND SHE WAS RE-STARTED ON NEW RO AND COMPLETED DIALYSIS WITHOUT FURTHER ISSUES. HTM REPLACED MEMBRANE, AND PUT BACK IN SERVICE. WILL NOT BE RETURNING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815082 WRO 300H SUBSYSTEM, WATER PURIFICATION FIP MAR COR PURIFICATION, INC. RO,WRO 300 H,115V~,60HZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown