BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOMIX 3+3/AS COMPOUNDER

    MDR report key: 381370 · Received March 8, 2002

    Report

    Report Number
    6000001-2002-00199
    Event Type
    Other
    Date Received
    March 8, 2002
    Date of Event
    February 7, 2002
    Report Date
    February 8, 2002
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEONATE RECEIVING TPN COMPOUNDED BY THIS DEVICE EXPERIENCED HYPERGLYCEMIA, WITH BLOOD GLUCOSE LEVEL REPORTED AS 300 MG/DL. AS A RESULT OF THE HYPERGLYCEMIA, THE STAFF QUESTION WHETHER THE TPN HAD THE CORRECT AMOUNT OF DEXTROSE. THE TPN WAS TAKEN DOWN AND SAVED FOR TESTING. THE CHEMISTRY LAB AT THE HOSPITAL TESTED THE TPN SOLUTION AND USING THEIR EQUIPMENT, THE SOLUTION TESTED HIGH FOR DEXTROSE. INITIALLY THE STAFF FELT THERE WAS A COMPOUNDER PROBLEM. THE STAFF SUSPECTED THIS COMPOUNDER WAS INACCURATE, AND REQUESTED THE COMPOUNDER BE EVALUATED FOR BOTH OVERFILL AND UNDERFILL. THIS COMPOUNDER WAS THEN TAKEN OUT OF SERVICE AND SENT IN FOR EVAL. ACCORDING TO THE RPTR, THE PT WAS ALREADY RECEIVING INSULIN INTRAVENOUSLY AT THE TIME OF THE HYPERGLYCEMIC EPISODE, AND THE DOSE WAS ADJUSTED PER PHSYICIAN'S ORDERS. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMIX 3+3/AS COMPOUNDER I.V. SOLUTION COMPOUNDER LHI BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY Required Intervention