BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABACUS V2.0 TPN CALCULATING SOFTWARE

    MDR report key: 1080765 · Received July 23, 2008

    Report

    Report Number
    1419106-2008-00012
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BAXA CORP.
    Product Code
    LNX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON THE INITIAL CONTACT TO BAXA, THE CUSTOMER PROVIDED THE ASSOCIATED DOCUMENTATION THAT IS PRODUCED WHEN A BAG IS COMPOUNDED ON THE MICROMACRO 12 (MM12). A REVIEW BY BAXA TECHNICAL SUPPORT OF THE ABACUS FORMULA AND SOLUTION LABELS, MIX CHECK REPORT AND THE MM12 BLACK BOX DATA (THE MM12 BLACKBOX DATA IS AN ONGOING DIALOGUE OF SYSTEM RECORDED BARCODE READS, SYSTEM LOGINS, AND OTHER SIGNIFICANT OPERATIONAL EVENTS STORED IN A LOG FILE FORMAT ON THE MM12 SYSTEM) FOR THE SUBJECT BAG SHOWED THAT THE MM12 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF CALCIUM AS ORDERED IN THE ABACUS SOFTWARE. INVESTIGATION HAS CONFIRMED THAT ABACUS SOFTWARE AND MICROMACRO 12 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF CALCIUM AS ORDERED IN THE ABACUS SOFTWARE.

    Description of Event or Problem · 1

    IN 2008, BAXA WAS NOTIFIED OF AN INCIDENT WHERE A PT EXPERIENCED AN 'ADVERSE EFFECT' DURING ADMINISTRATION OF A TPN BAG. THE PATIENT'S LAB RESULTS INDICATED ELEVATED LEVEL OF CALCIUM. THE CUSTOMER REPORTED THAT THEY WERE AIMING FOR 3.91% CONCENTRATION OF CALCIUM IN THE TPN ORDER AND GOT A READING OF 4.2% CONCENTRATION OF CALCIUM. BAXA WAS NOT INFORMED OF HOW THE CALCIUM CONCENTRATION WAS TESTED WITHIN THE TPN BAG. UPON FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFO, EXCEPT TO SAY THAT THEY HAD RULED THE COMPOUNDER OUT AS A SOURCE OF THE EVENT. UPON REVIEWING THE PATIENT'S LAB RESULTS, ALL OF THE PATIENT'S ELECTROLYTES WERE OUT OF RANGE AND THAT THE ADVERSE EFFECT' PERTAINED TO THE PATIENT'S CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS V2.0 TPN CALCULATING SOFTWARE ABACUS MULTI WORKSTATION LNX BAXA CORP. 8300-0047

    Patients

    Seq Age Sex Outcome Treatment
    1