BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON NXT

    MDR report key: 515734 · Received March 9, 2004

    Report

    Report Number
    1641965-2004-00003
    Event Type
    Other
    Date Received
    March 9, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 4, 2004
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A FIELD SERVICE REPRESENTATIVE FOR THE MANUFACTURER WAS NOTIFIED OF AN OVER-INFUSION INCIDENT DURING A PREVENTIVE MAINTENANCE VISIT. THE PUMP WAS REPORTEDLY PROGRAMMED TO DELIVER 1000 ML AT A RATE OF 40 ML/HR, BUT WAS FOUND TO HAVE INFUSED 1000 ML IN 12 HOURS. NO PT INJURY OCCURRED. NO FURTHER DETAILS CONCERNING THE DRUG INFUSED OR PT INFORMATION WERE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON NXT INFUSION PUMP FRN B. BRAUN MEDICAL, INC. 610 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention