BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABACUS V2.0 TPN CALCULATING SOFTWARE

    MDR report key: 1282025 · Received December 24, 2008

    Report

    Report Number
    1419106-2008-00016
    Event Type
    Other
    Date Received
    December 24, 2008
    Date of Event
    November 24, 2008
    Report Date
    November 24, 2008
    Manufacturer
    BAXA CORPORATION
    Product Code
    LNX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON THE INITIAL CONTACT TO BAXA, THE CUSTOMER STATED THAT THEY WERE NOT AUTHORIZED TO DISCUSS THE DETAILS OF THIS INCIDENT, BUT DID STATE THAT IT WAS "USER ERROR DURING ORDER ENTRY." THE CUSTOMER WAS ABLE TO PROVIDE THEIR ABACUS DATABASE AND COMPOUNDER DATABASE FOR EVALUATION. AN EXAMINATION OF THE ABACUS DATABASE REVEALED THAT THE ORDER WAS ENTERED ON (B)(6) 2008. THE ORDER CONTAINED THE FOLLOWING INGREDIENTS: 40 MEQ/DL NA CHLORIDE, 40 MEQ/DL NA ACETATE, 30 MEQ/DL K CHLORIDE. THE TOTAL VOLUME OF THE BAG WAS 1000 ML. THE PATIENT'S PREVIOUS DAY'S ORDER HAD A UNIT VALUE OF MEQ/L RATHER THAN THE SUBJECT'S ORDER UNIT VALUE OF MEQ/DL. THEREFORE, BASED ON THE INFORMATION PROVIDED FOR ANALYSIS, IT CAN BE CONCLUDED THAT THE LIKELY CAUSE OF THE OVER-DELIVERY WAS THE SELECTION OF MEQ/DL, RATHER THAN MEQ/L BY THE USER COMPLETING ORDER ENTRY. THE ABACUS DATABASE SHOWED THAT THE SOFTWARE DISPLAYED WARNING LIMITS FOR ACETATE, CHLORIDE AND POTASSIUM. RATIONALE WAS GIVEN TO ALL THREE WARNING LIMITS AS "OK" AND THE ORDER WAS COMPLETED. A SITE VISIT WAS CONDUCTED ON (B)(6) 2008, TO PROVIDE TECHNICAL ASSISTANCE. DURING THE SITE VISIT, EXTENSIVE ABACUS ORDER ENTRY TRAINING WAS CONDUCTED. ADDITIONAL HARD STOP WARNING LIMITS WERE IMPLEMENTED FOR SAFEGUARD, AND A WARNING LIMIT OVERRIDE SECTION WAS ADDED TO THEIR EXISTING ABACUS FORMULA LABEL. IF BAXA RECEIVES ADDITIONAL INFORMATION IN REGARDS TO THIS INCIDENT, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2008, BAXA WAS NOTIFIED BY THE CUSTOMER OF A PATIENT INVOLVED INCIDENT USING THE ABACUS V2.0 TPN CALCULATING SOFTWARE AND THE EXACTA-MIX 2400 COMPOUNDER FOR TPN PRODUCTION. IT WAS REPORTED THAT A PATIENT HAD RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-ANTICIPATED VOLUME OF SODIUM CHLORIDE, SODIUM ACETATE AND POTASSIUM CHLORIDE. THREE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER ON THIS INCIDENT, HOWEVER, THE CUSTOMER HAS ELECTED TO NOT SHARE ANY FURTHER DETAILS. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1