BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UF FILTER

    MDR report key: 7995181 · Received October 11, 2018

    Report

    Report Number
    7995181
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 10, 2018
    Manufacturer
    UNKNOWN
    Product Code
    JRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE UF FILTER HEAD FOR THE RO LOOP PLUMBED FOR CENTRAL BICARBONATE SYSTEM WAS MOLDED INCORRECTLY, SO THERE WAS NO FLOW TO THE INLET SIDE OF THE HOUSING HEAD. AN ADDITIONAL UF FILTER PLUMBED IN PARALLEL WITH THE DEFECTIVE DEVICE PREVENTED IMMEDIATE RECOGNITION OF DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796744 UF FILTER UF HOUSING HEADER CAP JRS UNKNOWN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1