BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTITASK OPERATING SYSTEM FOR AUTOMIX COMPOINDER

    MDR report key: 210256 · Received February 15, 1999

    Report

    Report Number
    210256
    Event Type
    Death
    Date Received
    February 15, 1999
    Date of Event
    December 31, 1998
    Report Date
    February 11, 1999
    Manufacturer
    CLINTEC NUTRITION CO.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ORDER READING 1/2 NORMAL SALINE WITH 1/2 U/CC HEPARIN AT 1CC/HOUR WAS REC'D BY PHARMACY. THE SOLUTION WAS COMPOUNDED USING THE MULTITASK OPERATING SYSTEM. SODIUM CHLORIDE 77MEQ WAS ENTERED INTO THE SYSTEM FOR COMPOUNDING A 24 ML BAG (WITH 100 ML OVERFILL). PROBLEMS IDENTIFIED INCLUDED LACK OF CLEARLY DISTINGUISHABLE SCREENS FOR VITAL DRUG ALERTS, POOR LABEL FORMAT AND CLARITY OF LABELS, COMPLEX ORDER ENTRY PROCESS, SCREENS DEPICTING SOLUTION AND ADDITIVE ASSIGNED STATIONS AND ID THAT APPEAR AT THE END OF ORDER ENTRY ALONG WITH WARNING SCREENS, CLINICALLY INSIGNIFICANT WARNINGS APPEAR AS FREQUENTLY AS VITAL WARNINGS, NO ACTION REQUIRED BY OPERATOR, SUCH AS PASSWORD OR OTHER RESPONSE TO ASSURE THAT VITAL WARNING IS ACKNOWLEDGED.

    Description of Event or Problem · 2

    AN ORDER READING 1/2 NORMAL SALINE WITH 1/2 U/CC HEPARIN AT 1CC/HOUR WAS REC'D BY PHARMACY. THE SOLUTION WAS COMPOUNDED USING THE MULTITASK OPERATING SYSTEM. SODIUM CHLORIDE 77MEQ WAS ENTERED INTO THE SYSTEM FOR COMPOUNDING A 24 ML BAG (WITH 100 ML OVERFILL). PROBLEMS IDENTIFIED INCLUDED LACK OF CLEARLY DISTINGUISHABLE SCREENS FOR VITAL DRUG ALERTS, POOR LABEL FORMAT AND CLARITY OF LABELS, COMPLEX ORDER ENTRY PROCESS, SCREENS DEPICTING SOLUTION AND ADDITIVE ASSIGNED STATIONS AND ID THAT APPEAR AT THE END OF ORDER ENTRY ALONG WITH WARNING SCREENS, CLINICALLY INSIGNIFICANT WARNINGS APPEAR AS FREQUENTLY AS VITAL WARNINGS, NO ACTION REQUIRED BY OPERATOR, SUCH AS PASSWORD OR OTHER RESPONSE TO ASSURE THAT VITAL WARNING IS ACKNOWLEDGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTITASK OPERATING SYSTEM FOR AUTOMIX COMPOINDER COMPUTER OPERATING SYSTEM (SOFTWARE) LHI CLINTEC NUTRITION CO. VERSION 2.3 'E' *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DAY Death
    2 9 DAY Death