BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABACUS V2.0 TPN CALCULATING SOFTWARE

    MDR report key: 1698731 · Received May 24, 2010

    Report

    Report Number
    1419106-2010-00012
    Event Type
    Other
    Date Received
    May 24, 2010
    Date of Event
    April 25, 2010
    Report Date
    April 27, 2010
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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, SELECTED THE CORRECT PT BUT THEN MISTAKENLY SELECTED THE ORDER FROM 2 DAY PRIOR (CONTAINING 70 MEQ POTASSIUM) INSTEAD OF THE PREVIOUS DAYS ORDER (CONTAINING NO POTASSIUM). THE CUSTOMER STATES THE PHARMACIST FAILED TO CAREFULLY CHECK THE ORDER DATES. IN ADDITION, THE PHARMACIST VERIFICATION OF THE ABACUS FORMULA LABEL AND BAG LABEL FAILED TO IDENTIFY THE CONTENTS OF THE BAG PRIOR TO INFUSION. THE CUSTOMER STATES THAT THE ORDER DISCREPANCY DID NOT CAUSE OR CONTRIBUTE TO THE PT'S FINAL CONDITION. BAXA HAS MADE ATTEMPTS ON (B)(4), 2010 TO GATHER THE ASSOCIATED ABACUS DOCUMENTATION THAT IS PRODUCED WHEN AN ORDER IS COMPLETED AND TO INQUIRE ABOUT THE FACILITY'S ORDER VERIFICATION PROCESS. TO DATE, THE CUSTOMER HAS ONLY PROVIDED ADD'L PT INFO. BAXA WILL CONTINUE TO GATHER THE REQUESTED INFO IN ORDER TO ASSIST THE FACILITY IN MITIGATING THIS TYPE OF ISSUE IN THE FUTURE. INVESTIGATION HAS CONFIRMED THAT THE ABACUS CALCULATING SOFTWARE PERFORMED AS DESIGNED AND DELIVERED THE VOLUME OF POTASSIUM AS ORDERED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, BAXA WAS NOTIFIED BY THE CUSTOMER OF A PT INVOLVED INCIDENT USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE FOR TPN PRODUCTION. IT WAS REPORTED THAT THIS PT RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-DESIRED QUANTITY OF POTASSIUM. THE BAG WAS INFUSED AND THEN REMOVED AFTER THE PT'S BLOOD WORK INDICATED THAT A HIGHER THAN EXPECTED LEVEL OF POTASSIUM WAS PRESENT. THE PT WAS GIVEN KAYEXALATE IN ORDER TO TREAT THE HIGH POTASSIUM LEVEL. THE PT HAS SINCE DECEASED PER PT'S FAMILY REQUEST TO WITHDRAW CARE EXCEPT COMFORT CARE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR