BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDFUSION 3500

    MDR report key: 1920567 · Received November 17, 2010

    Report

    Report Number
    1920567
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    NURSING PROGRAMMED TRANEXAMIC ACID 40 MG/ML, PATIENT WEIGHT 3.7 KG, 60 ML BD SYRINGE SIZE, DOSE 10 MG/KG/HOUR. THE PUMP CALCULATED THE DOSE AT 3.7 ML/HOUR. 2ND LINE LED DISPLAY READ CONCENTRATION 10 MG / HOUR ALTHOUGH TOP LINE READS 40 MG/ML. DOSE INFUSED AT 4 TIMES ORDERED DOSE. PATIENT REQUIRED ADDITIONAL MONITORING BUT APPEARS UNHARMED. DRUG LIBRARY WAS UPDATED RECENTLY. THE CHANGE IN THE 2ND LINE CONCENTRATION APPEARS TO HAVE OCCURRED AT THAT TIME. THE CONCENTRATION DOSE FOR TRANEXAMIC ACID DOES NOT MATCH THE LIBRARY UPGRADE OR PAST LIBRARY. THE DRUG TRANEXAMIC ACID WAS NOT UPDATED WITH THAT DRUG LIBRARY UPGRADE. ONLY LASIX AND HEPARIN WERE CHANGED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DRUG LIBRARY UPGRADE SOMEHOW CHANGED THE CONCENTRATION====================== MANUFACTURER RESPONSE FOR SYRINGE INFUSION PUMP, MEDFUSION 3500======================WORKING WITH US TO DETERMINE REASON THAT CONCENTRATION LINE WAS UPDATED WITH DRUG LIBRARY ON UNRELATED MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 3500 SYRINGE INFUSION PUMP FRN SMITHS MEDICAL 3500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 DA Hospitalization| R