BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1242515 · Received November 21, 2008

    Report

    Report Number
    2016493-2008-00189
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 23, 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

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNDER INFUSION OF HERCEPTIN. HERCEPTIN WAS INFUSING WITH 290 ML TO RUN OVER 30 MINUTES. AFTER 30 MINUTES, THERE WAS A RESIDUAL OF 25ML AND AN ACTUAL RUN TIME WAS REPORTED AS 40 MINUTES. NO PT 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