BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABACUS V2.0 TPN CALCULATING SOFTWARE

    MDR report key: 1933892 · Received November 21, 2010

    Report

    Report Number
    1419106-2010-00021
    Event Type
    Death
    Date Received
    November 21, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER PERFORMED EXTENSIVE REVIEW OF USER'S ABACUS DATABASE, (B)(4) COMPOUNDER DATABASE, (B)(4) BLACKBOX FILES AND EVENT LOG. DURING THE COURSE OF OUR INVESTIGATION, IT WAS DETERMINED THAT THE PHARMACIST THAT ENTERED THE ORDER SELECTED THE WRONG PATIENT TYPE AND TEMPLATE FOR THE ORDER IN QUESTION. ABACUS SOFTWARE HAS A FEATURE CALLED "WARNING LIMITS", WHICH CAN BE IMPLEMENTED FOR INDIVIDUAL INGREDIENTS TO PROVIDE A WARNING WHEN A HIGHER-THAN-TYPICAL VOLUME FOR AN INDIVIDUAL INGREDIENT IS ENTERED, IN ORDER TO MITIGATE THE POTENTIAL FOR AN OVER-DELIVERY. WARNING LIMITS WERE NOT EMPLOYED FOR THIS TEMPLATE. IN 2009, BAXA FORMALLY NOTIFIED THIS FACILITY IN WRITING THAT THESE SAFETY FEATURES WERE NOT EMPLOYED FOR THIS TEMPLATE AND ATTEMPTED TO PROVIDE ASSISTANCE IN SETTING UP THE LIMITS, WHICH THE FACILITY DECLINED. (B)(4). IN SUMMARY, BAXA HAS CONCLUDED THAT THIS EVENT WAS CAUSED BY THE INADVERTENT ENTRY OF THE INTENDED CAGLUC VOLUME INTO THE NACL VOLUME IN ABACUS. THE ABACUS SOFTWARE AND (B)(4) COMPOUNDER OPERATED AS INTENDED AND DELIVERED THE VOLUMES AS ORDERED. BAXA HAS BEEN WORKING WITH THE USER FACILITY TO MODIFY THEIR ORDER TEMPLATES AND EMPLOY WARNING LIMITS TO PREVENT A RECURRENCE OF THIS ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2010, AN ELECTROLYTE BAG ORDER WAS ENTERED INTO (B)(6) (A PHARMACY INFORMATION SYSTEM NOT MANUFACTURED OR SUPPLIED BY BAXA) CONTAINING DEXTROSE 10%, HEPARIN, CALCIUM, POTASSIUM, AND SODIUM. THE LABEL FROM (B)(6) WAS TRANSCRIBED INTO ABACUS IN ORDER TO COMPOUND THIS BAG USING THE (B)(4) COMPOUNDER. THE VOLUME OF CALCIUM TO BE ADDED TO THE COMPOUNDED SOLUTION WAS INADVERTENTLY ENTERED INTO BOTH THE SODIUM AND CALCIUM FIELDS VIA KEYSTROKE ERROR. THE INADVERTENT OVER-DELIVERY OF SODIUM MAY HAVE LED TO THE PATIENT'S DEATH. BAXA WAS NOT MADE AWARE OF THIS INCIDENT UNTIL 11/17/2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS V2.0 TPN CALCULATING SOFTWARE ABACUS SINGLE WORKSTATION LHI BAXA CORP. 8300-0046

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Death