BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUEST MEDICAL, INC.

    MDR report key: 11626934 · Received March 25, 2021

    Report

    Report Number
    11626934
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 17, 2021
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MPS MODULE #3710 ON THE BYPASS MACHINE WHICH HAD JUST RETURNED FROM BEING SERVICED MALFUNCTIONED WHILE ON BYPASS. I WAS DELIVERING MY LAST DOSE OF CARDIOPLEGIA WHEN THIS HAPPENED. MY POTASSIUM PACKET HAD 25ML OF POTASSIUM IN IT. I HAD MY MACHINE SET AT 2 MEQ/1. WHEN I TURNED ON THE MACHINE TO DELIVER THERE WAS A DELAY BEFORE THE AUTOMATIC CLAMP OPENED. ONCE THE AUTOMATIC CLAMP OPENED, AT 17:34, IT IMMEDIATELY BOLUSED THE ENTIRE 25MLS IN TO THE CARDIOPLEGIA CIRCUIT. THAT DOSE WENT INTO THE PATIENT AND CAUSED AN EXTRA 45 MINUTES ON BYPASS WHILE WE HAD TO WAIT FOR THE POTASSIUM TO WASH OUT AND THE HEART TO RETURN TO A NORMAL RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469817 QUEST MEDICAL, INC. MPS 2 CONSOLE DTR QUEST MEDICAL, INC. MPS 2

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R