BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 12438371 · Received September 8, 2021

    Report

    Report Number
    12438371
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    July 3, 2021
    Report Date
    August 23, 2021
    Manufacturer
    BAXTER CORPORATION ENGLEWOOD
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDICALLY COMPLEX CHILD ADMITTED FOR CONCERNS OF ACUTE ON CHRONIC PANCREATITIS. PATIENT NOTHING BY MOUTH (NPO) AND TOTAL PARENTERAL NUTRITION (TPN) DEPENDENT FOR NUTRITION. PATIENT WITH ONGOING HIGHER SODIUM AND CHLORIDE LEVELS; TEAM ADJUSTING NA, CL, AND K CONCENTRATION IN TPN ON DAILY BASIS IN EFFORT TO NORMALIZE ELECTROLYTES ON BASIC METABOLIC PANEL (BMP). FOLLOWING PUMP MALFUNCTION, PATIENT SODIUM INCREASED 152 > 158, CHLORIDE 116> 121, AND BUN 25 > 33 DESPITE LOWER THESE DAILY IN TPN. INCREASED SODIUM COULD HAVE BEEN FROM DEHYDRATION / STARTED 1/2 NORMAL SALINE (NS), WHICH IS STILL RUNNING / SODIUM STABLE. EVENT REQUIRED PATIENT MONITORING TO CONFIRM THAT IT RESULTED IN NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339347 EXACTAMIX SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER CORPORATION ENGLEWOOD H9382400-DY

    Patients

    Seq Age Sex Outcome Treatment
    1 4015 DA