BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROMACRO COMPOUNDER

    MDR report key: 86647 · Received April 22, 1997

    Report

    Report Number
    1419106-1997-00001
    Event Type
    Other
    Date Received
    April 22, 1997
    Date of Event
    April 10, 1997
    Report Date
    April 22, 1997
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE A TPN SOLUTION WAS BEING ADMINISTERED TO A NEONATE WEIGHING 0.6 KGS, A PRECIPITATE WAS OBSERVED IN THE SOLUTION. THE SOLUTION WAS DISCONTINUED. TESTING OF THE BABY SHOWED AN ELEVATION OF POTASSIUM. THE DISCONTINUED BAG WAS SUBSEQUENTLY TESTED AND SHOWED 27 MILIMOLE/LITER OF POTASSIUM THOUGH NONE HAD BEEN ORDERED VIA THE COMPOUNDER FORMULARY. THE INFANT WAS TREATED FOR ELEVATED POTASSIUM. THE CONDITION OF THE INFANT IS IMPROVED TO THE SAME AS ITS PREMATURE TWIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMACRO COMPOUNDER PHARMACY COMPOUNDER LHI BAXA CORP. MM23 COMPOUNDER *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R