BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMIX 3+3 COMPOUNDER

    MDR report key: 214394 · Received March 15, 1999

    Report

    Report Number
    6000001-1999-00092
    Event Type
    Death
    Date Received
    March 15, 1999
    Date of Event
    February 3, 1999
    Report Date
    February 12, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT A PT ON CYCLIC HOME TOTAL PERENTERAL NUTRITION WAS FOUND DEAD AFTER THE TOTAL PERENTERAL NUTRITION INFUSION WAS COMPLETED. HE STATED THAT THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME, BUT THAT IT WAS UNEXPECTED, AND THAT THE AUTOPSY WILL NOT BE COMPLETED FOR SEVERAL WEEKS. THEREFORE, HE WANTS TO HAVE THE UNUSED BAGS OF TOTAL PERENTERAL NUTRITION WHICH HAD BEEN PREPARED FOR THE PT ANALYZED CHEMICALLY. HE STATED THE EMPTY BAG AND TUBING IN USE AT THE TIME OF THE INCIDENT ARE NOT AVAILABLE. THE CUSTOMER AGREED TO SEND THE UNIT, WHICH HAD BEEN USED TO COMPOUND THE BASE TOTAL PERENTERAL NUTRITION SOLUTION, TO PRODUCT SERVICES FOR EVALUATION. THE PT WAS A 17-YEAR-OLD FEMALE WITH A DIAGNOSIS OF LEUKEMIA, FOR WHICH SHE HAD UNDERGONE A SUCCESSFUL BONE MARROW TRANSPLANT. SHE WAS APPARENTLY RECEIVING TOTAL PERENTERAL NUTRITION AS A DIETARY SUPPLEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR