BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABACUS TPN CALCULATING SOFTWARE

    MDR report key: 909814 · Received September 7, 2007

    Report

    Report Number
    1419106-2007-00009
    Event Type
    Other
    Date Received
    September 7, 2007
    Date of Event
    August 11, 2007
    Report Date
    August 11, 2007
    Manufacturer
    BAXA CORPORATION
    Product Code
    LNX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE ORDER FORM AND THE DATABASE REVEALED THAT THE SOFTWARE FUNCTIONED AS DESIGNED. THE SAFETY FEATURES (INGREDIENT VOLUME WARNINGS) RESIDENT IN THE SOFTWARE WERE NOT PROPERLY EMPLOYED. THE VERIFICATION LABEL ALONG WITH THE ASSOCIATED DOCUMENTATION THAT IS PRODUCED WITH THE ORDER OF THE TPN BAG CLEARLY INDICATE THE VOLUME OF RANITIDINE IN THE TPN SOLUTION; PHARMACIST AND PHYSICIAN VERIFICATION OF THE TPN BAG FAILED TO IDENTIFY THE HIGHER -THAN-DESIRED ORDERED AMOUNT OF RANITIDINE. A REVIEW OF THE PRODUCT HAZARD ANALYSIS (PHA) AND CUSTOMER COMPLAINT DATA FOR THIS PRODUCT WAS CONDUCTED, AND IT WAS DETERMINED THAT THIS ISSUE NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN IS EXPECTED FOR THE DEVICE, AS DOCUMENTED IN THE PHA.

    Description of Event or Problem · 1

    IN 2007, BAXA WAS NOTIFIED OF AN INCIDENT THAT RESULTED IN A PATIENT REQUIRING ADDITIONAL MONITORING FOR POTENTIAL SIDE EFFECTS FROM AN OVER DOSE OF RANITIDINE (ZANTAC). THE CUSTOMER REPORTED THAT WHILE USING THE ABACUS TPN CALCULATING SOFTWARE FOR CREATING A TPN SOLUTION, THAT A PATIENT WAS INFUSED WITH A TPN SOLUTION THAT CONTAINED A HIGHER-THAN-DESIRED VOLUME OF RANITIDINE (ZANTAC) FOR THIS PARTICULAR PATIENT. THE DOSE OF RANITIDINE (ZANTAC), RATHER THAN BEING 24MG/DAY WAS ENTERED AS 24MG/KG, APPROXIMATELY 7.6 TIMES THE ORIGINAL ORDERED AMOUNT. THE CUSTOMER REPORTED THAT NO ADVERSE EVENT RESULTED FROM THE OVER-DELIVERY OF RANITIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS TPN CALCULATING SOFTWARE ABACUS SINGLE WORK STATION LNX BAXA CORPORATION 8300-0046 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention