BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPN PC PLUS

    MDR report key: 493038 · Received October 28, 2003

    Report

    Report Number
    1419106-2003-00003
    Event Type
    Injury
    Date Received
    October 28, 2003
    Date of Event
    October 26, 2003
    Report Date
    October 26, 2003
    Manufacturer
    BAXA CORP.
    Product Code
    LNX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXA CORPORATION WAS MADE AWARE OF A USER ORDER ENTRY ERROR THAT LEAD TO A PATIENT INJURY. THE HOSPITIAL REPORTED THAT WHILE USING BAXA ORDER ENTRY SOFTWARE PRODUCT 'TPN PC+' TO FORMULATE A CHEMOTHERAPY COMPOUND FOR A PATIENT, THE HOSPITAL MISTAKENLY SELECTED NORMAL SALINE MEASURED IN MEQ RATHER THAN IN ML. THIS RESULTED IN AN INCORRECT SOLUTION BEING MADE, WHICH WAS DELIVERED TO A PATIENT. THIS MAY HAVE RESULTED IN A PATIENT RECEIVING VEIN DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPN PC PLUS PHARMACY COMPOUNDING SYSTEM LNX BAXA CORP. TPN PC+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention