BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABACUS SOFTWARE

    MDR report key: 2170104 · Received June 20, 2011

    Report

    Report Number
    1419106-2011-00009
    Event Type
    Other
    Date Received
    June 20, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE EVENTS OR PT INJURY RESULTED FROM THE INFUSION OF THIS TPN. REVIEW OF DATABASE BLACK BOX FILES WAS PERFORMED. THE DEVICE OPERATED AS INTENDED AND DELIVERED THE CORRECT ORDER AMOUNT OF THE REQUESTED INGREDIENT. BAXA TECHNICAL SUPPORT REITERATED, TO THE CUSTOMER, THE CORRECT USAGE OF THE ABACUS SOFTWARE AS STATED IN THE OPERATOR'S MANUAL. A REVIEW OF RISK DOCUMENTATION WAS PERFORMED, AND IT HAS BEEN CONCLUDED THAT THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED. BAXA CLINICAL PHARMACY SPECIALIST ISSUED A DUTY TO WARN LETTER TO THE DIRECTOR OF PHARMACY AT THE FACILITY REGARDING THE MISUSE OF ABACUS. REFER TO ATTACHMENT AT THE END OF THIS MDR FOR CLARIFICATION OF TERMS FOUND IN THE ABOVE NARRATIVE. BAXA REQUESTED ALL OF THE INFO NEEDED TO BE ABLE TO INVESTIGATE THE REPORTED ISSUE. BAXA WAS PROVIDED WITH THE ABACUS DATABASE AND THE BLACK BOX FILES. BASED ON THE PROVIDED INFO, THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE A DATA ENTRY ERROR OF THE ORDERED TPN THERAPY. THE BLACK BOX DATA FOR THE EM2400 COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUMES OF THE REQUESTED INGREDIENTS. THE REVIEW ALSO SHOWS THAT THE USER OVERRODE THE OSMOLARITY WARNING LIMIT. THIS WARNING LIMIT WAS TRIGGERED IN RESPONSE TO THE INCREASE IN DEXTROSE; A GREATER INCREASE IN SOLUTE PARTICLES RATHER THAN THE MOLES OF THE SOLUTE. BAXA TECHNICAL SUPPORT ASSISTED THE FACILITY IN CREATING A WARNING LIMIT FOR PERIOD AND DURATION. THIS LIMIT WARNS WHEN THEY ATTEMPT TO SET AN INFUSION PERIOD OUTSIDE OF A SET PREDETERMINED VALUES. BLACK BOX DATA: THIS IS A LOG OF THE COMMANDS THE COMPOUNDER RECEIVES AND THE ACTIONS THE COMPOUNDER TAKES TO PRODUCE THE TPN BAG. BLACK BOX DATA STORES THE EXACT ORDER OF COMMANDS THE COMPOUNDER RECEIVED IN ORDER TO CREATE A TPN BAG. A REVIEW OF THE BLACK BOX DATA REVEALS IF THE COMPOUNDER CORRECTLY PUMPED/DELIVERED THE REQUESTED INGREDIENTS IN THE PROPER ORDER. PERIOD AND DURATION: PERIOD AND DURATION ARE TIME DESCRIPTIONS THAT ARE NECESSARY FOR THE SOFTWARE TO COMPUTE HOW MUCH OF EACH DAY'S INGREDIENT DOSE WILL BE INCLUDED IN EACH TPN SOLUTION. PERIOD IS THE TIME IN HOURS THAT DEFINES AN INFUSION DAY. DURATION IS THE TIME IN HOURS THAT AN INDIVIDUAL BAG WILL INFUSE AT THE CALCULATED RATE. THE SOFTWARE CALCULATES THE PERCENTAGE OF THE "PER DAY" DOSE BY COMPARING THE PERIOD TO A FULL DAY OF INFUSION. WARNING LIMITS: TERM USED IN ABACUS TO DESCRIBE PRESET DOSING THRESHOLDS, AND IS A FEATURE THAT ALLOWS USER TO CREATE ALERTS FOR POTENTIAL DOSING ERRORS DURING ORDER-ENTRY AND/OR CALCULATION. THE ABACUS SOFTWARE HAS A SPECIFIC SET OF "BAXA ONLY" LIMITS FOR THE PURPOSE OF PREVENTING GROSS DOSING ERRORS FOR MOST TOTAL PARENTERAL NUTRITION INGREDIENTS, AS WELL AS INSTITUTIONAL LIMITS FOR THE PURPOSE OF HELPING USERS ESTABLISH A FIRST LINE OF DOSING ERROR PROTECTION THAT IS SPECIFIC TO THE NEEDS OF THE CUSTOMER. OSMOLARITY CALCULATION: OSMOLARITY IS THE MEASURE OF SOLUTE CONCENTRATION, DEFINED AS THE NUMBER OF OSMOLES (OSM) OF SOLUTE PER LITRE (L) OF SOLUTION. IT IS USED TO MEASURE MOLES OF SOLUTE PARTICLES RATHER THAN MOLES OF SOLUTE. WITHIN ABACUS OSMOLARITY, IN MOSM/ML, IS STORED AND ACCUMULATED AS AN INTRINSIC VALUE FOR EACH ITEM IN THE FORMULARY. THE PT WILL BE INFUSED THROUGH A CENTRAL LINE IF THERE ARE TOO MANY SOLUTE PARTICLES IN THE SOLUTION, OTHERWISE INFUSION WILL BE CONDUCTED THROUGH A PERIPHERAL LINE.

    Description of Event or Problem · 1

    ON (B)(6), THE PHARMACIST CALLED BAXA TECHNICAL SUPPORT, TO REPORT THAT A PT RECEIVED A TPN THERAPY BAG WITH A HIGHER THAN ANTICIPATED AMOUNT OF DEXTROSE. IN ORDER TO TREAT THE PT, INSULIN AND FLUIDS WERE ADMINISTERED IN RESPONSE TO THEIR INCREASED GLUCOSE LEVELS. NO ADVERSE EVENTS OR PT INJURY RESULTED FROM THE INFUSION OF THIS TPN. IT WAS FOUND THAT THE PHARMACIST INADVERTENTLY DROPPED THE "2" IN THE PERIOD FIELD; "4" WAS ENTERED INSTEAD OF "24" HOURS. THIS CAUSED DEXTROSE TO BE OVER-DELIVERED 6 TIMES (151 ML INSTEAD OF THE INTENDED 25 ML) BECAUSE DEXTROSE WAS A TIME-BASED ORDERING METHOD, AND THE OTHER INGREDIENTS WERE WEIGHT-BASED, AND THEREFORE UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS SOFTWARE ABACUS TPN CALCULATION SOFTWARE LHI BAXA CORP. 8300-0046

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Required Intervention