BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA

    MDR report key: 1942582 · Received November 29, 2010

    Report

    Report Number
    1942582
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 29, 2010
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AT 12:00 P.M., SET PUMP RATE AND VOLUME FOR 4 HOURS TO ADMINISTER NAPHOS 12 MMOL IV. AT 12:30 P.M., NAPHOS IV BAG WAS EMPTY AND THE NACL BAG WAS INFUSING. PUMP INDICATED NAPHOS HAD 3 HOURS AND SOME MINUTES LEFT. AS A RESULT, NAPHOS WAS ADMINISTERED IN 30 MINUTES INSTEAD OF 4 HOURS. VITAL SIGNS STABLE, NO ARRHYTHMIAS, AND NO REDNESS, PHELEBITIS, OR INFILTRATION AT IV SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA INFUSION PUMP FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *