BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABACUS V2.0 TPN CALCULATING SOFTWARE

    MDR report key: 1083564 · Received July 24, 2008

    Report

    Report Number
    1419106-2008-00013
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    BAXA CORPORATION
    Product Code
    LNX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S SUBSEQUENT INVESTIGATION REVEALED THAT THE PHARMACIST, WHO ENTERED THE SUBJECT ORDER WITHIN THE ABACUS CALCULATING SOFTWARE, MISTAKENLY ENTERED A VALUE OF 3ML/KG OF PEDIATRIC TRACE ELEMENTS IN ADDITION TO 3ML OF ADULT TRACE ELEMENTS. THE FACILITIES PROCEDURE STATES THAT PATIENTS SHOULD RECEIVE ADULT TRACE ELEMENTS AND NO PEDIATRIC TRACE ELEMENTS. PHARMACIST VERIFICATION OF THE ORDERED INGREDIENTS FAILED TO IDENTIFY THE ADDITIONAL 84ML OF PEDIATRIC TRACE ELEMENTS. WITH THE ASSISTANCE OF BAXA TECHNICAL SUPPORT, THE IMPORTANCE OF ABACUS SOFTWARE WARNING LIMITS AND INGREDIENTS DOSING RULES WERE ADDRESSED WITH THE CUSTOMER AND A NEW CATASTROPHIC WARNING LIMIT WAS CREATED FOR PEDIATRIC TRACE ELEMENTS FOR ALL PEDIATRIC AND NEONATAL PATIENTS. THIS WARNING LIMIT WILL NOTIFY THE USER WHEN THE VALUE FOR PEDIATRIC TRACE ELEMENTS HAS EXCEEDED THE MAXIMUM VALUE OF 5ML. INVESTIGATION HAS CONFIRMED THAT THE ABACUS CALCULATING SOFTWARE PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF PEDIATRIC TRACE ELEMENTS AS ORDERED.

    Description of Event or Problem · 1

    BAXA WAS NOTIFIED ON 06/25/2008 THAT A PATIENT HAD RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-DESIRED QUANTITY OF TRACE ELEMENTS. THE BAG WAS INFUSED FOR 18 HOURS AND THEN REMOVED ONCE THE ISSUE WAS DISCOVERED. THE PATIENT'S BLOOD WORK INDICATED HIGHER-THAN-EXPECTED LEVELS OF ZINC AND CHROMIUM. HOWEVER, NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. THE PATIENT IS IN STABLE CONDITION AND DID NOT EXPERIENCE ANY ADVERSE SYMPTOMS AS A RESULT OF THE INFUSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention