BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1242516 · Received November 21, 2008

    Report

    Report Number
    2016493-2008-00198
    Event Type
    Other
    Date Received
    November 21, 2008
    Date of Event
    October 22, 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

    .

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNDER INFUSION OF CPT-11. CPT-11 WAS INFUSING WITH 562 ML TO RUN OVER 90 MINUTES. AFTER 90 MINUTES, THERE WAS A RESIDUAL OF 50 ML AND AN ACTUAL RUN TIME WAS REPORTED AS 105 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