BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1242510 · Received November 21, 2008

    Report

    Report Number
    2016493-2008-00183
    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

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDER INFUSION OF NORMAL SALINE (NSS). NSS WAS INFUSING WITH 1000ML TO RUN OVER 1 HOUR. AFTER 1 HOUR THERE WAS A RESIDUAL OF 100ML AND AN ACTUAL RUN TIME WAS 1 HOUR 10 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