BEUDAMED
    FDA Adverse Event Death Summary report: N

    I.V. SOLUTION COMPOUNDER

    MDR report key: 505511 · Received January 7, 2004

    Report

    Report Number
    6000001-2003-09502
    Event Type
    Death
    Date Received
    January 7, 2004
    Date of Event
    October 28, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    LHI
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED A RISE IN SERUM SODIUM IN 10/2003. THE PT HAD STARTED TPN THERAPY THE PREVIOUS DAY AT APPROX 9:00A.M. THE SERUM SODIUM LEVEL AT THAT TIME WAS 120. A SECOND BAG OF TPN WAS HUNG 12 HOURS LATER. THREE HOURS AFTER THE START OF THE SECOND TPN, THE PT'S SERUM SODIUM LEVEL WAS 169. THREE DAYS AFTER STARTING THE THERAPY, THE SERUM SODIUM LEVEL WAS 180. REPORTEDLY, TPN WAS CONTINUED TWICE IN THE LAST THREE DAYS OF THAT MONTH. THE PT HAD AN EXCHANGE TRANSFUSION, BUT THE DATE WAS NOT PROVIDED. VAGUE INFO WAS RECEIVED FROM THE FACILITY INDICATING THAT THE COMPOUNDED TPN SOLUTION WAS NOT ACCURATE. THE PT'S FAMILY MEMBER MADE THE DECISION TO END LIFE SUPPORT THREE DAYS AFTER STARTING THE THERAPY AND THE PT EXPIRED ON THAT DATE. THE FACILITY HAS DECLINED TO RELEASE ANY ADDITIONAL INFO AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death