BEUDAMED
    FDA Adverse Event Death Summary report: N

    TPN-PC PLUS MULTIUSER SOFTWARE VER. 3.40

    MDR report key: 242801 · Received September 29, 1999

    Report

    Report Number
    1419106-1999-00003
    Event Type
    Death
    Date Received
    September 29, 1999
    Date of Event
    August 1, 1999
    Report Date
    September 28, 1999
    Manufacturer
    BAXA CORP.
    Product Code
    LNX
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT A HYDRATION SOLUTION WAS ORDERED FOR A PT. THE PHARMACIST USED A BAXA CORPORATION, COMPOUNDER AND ASSOCIATED SOFTWARE TO PREPARE THE SOLUTION BAG. THE SOLUTION WAS ORDERED TO CONTAIN AN UNSPECIFIED AMOUNT OF DEXTROSE AND 7MEQ OF SODIUM CHLORIDE. THE ORDER WAS MISTAKENLY ENTERED BY THE PHARMACY AS 7 GM PERCENT RATHER THAN 7 MEQ. THIS RESULTED IN A SIGNIFICANT OVERDOSE OF SODIUM CHLORIDE AND A HYPERTONIC SOLUTION. THE HOSP DELIVERED THIS SOLUTION TO A PT AND THE PT WAS REPORTED TO HAVE DIED. THE HOSP WAS UNABLE TO PROVIDE SPECIFIC INFO CONCERNING THE AGE OF THE PT OR DATE OF DEATH. THE HOSP NEGLECTED TO UTILIZE ONE OF THE SAFETY FEATURES OF THE SOFTWARE. WARNING LIMITS CAN BE SET IN THE SOFTWARE TO PREVENT THIS TYPE OF OCCURRENCE. IN ADDITION, THE SYSTEM PROVIDED A TPN BAG LABEL THAT CLEARLY REFLECTED THE ORDER AS ENTERED. THE HOSP STAFF FAILED TO IDENTIFY THE RISKS ASSOCIATED WITH DELIVERING THIS ADMIXTURE OR DID NOT REVIEW THE LABELED CONTENTS. THE DIRECTOR OF PHARMACY AT THE HOSP INDICATED THAT THEY DID NOT SEE A PRODUCT DEFECT IN THE CO'S PRODUCT, AND THAT THIS WAS CLEARLY A USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPN-PC PLUS MULTIUSER SOFTWARE VER. 3.40 TPN COMPOUNDING SYSTEM LNX BAXA CORP. 03-3M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death