BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1242505 · Received November 21, 2008

    Report

    Report Number
    2016493-2008-00200
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 28, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNDER INFUSION OF IRON SUCROSE. IRON SUCROSE WAS INFUSING WITH 265ML TO RUN OVER 2 HOURS. AFTER 2 HOURS THERE WAS A RESIDUAL OF 50ML AND ACTUAL RUN TIME WAS REPORTED AS 2 HOURS 20 MINUTES. NO PATIENT HARM. PRODUCT RETURN IS NOT EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SYSTEM FRN, INFUSION SYSTEM FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other