BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MDDS/EHR DEVICE

    MDR report key: 5067746 · Received September 7, 2015

    Report

    Report Number
    MW5056072
    Event Type
    Injury
    Date Received
    September 7, 2015
    Date of Event
    August 21, 2015
    Report Date
    September 7, 2015
    Manufacturer
    PRO TOUCH/KINDRED
    Product Code
    NSX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    THERE WAS INTERVAL INCREASE OF POTASSIUM LEVEL IN A CASE ON BOTH POTASSIUM SUPPLEMENTS AND A POTASSIUM SPARING DIURETIC FOR END STAGE HEART FAILURE. A POTASSIUM LEVEL WAS 5.7 YET BOTH THE POTASSIUM AND THE DIURETIC WERE ADMINISTERED BECAUSE THE HIGH POTASSIUM LEVEL WAS NOT SEEN HAVING BEEN ELECTRONICALLY SENT TO THE MDDS WITHOUT NOTICE OR WARNING. ADDITIONAL THERAPY WAS NEEDED TO CORRECT THE RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590823 MDDS/EHR DEVICE EHR/MDDS NSX PRO TOUCH/KINDRED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| O| R