BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1121326 · Received August 13, 2008

    Report

    Report Number
    2016493-2008-00117
    Event Type
    Other
    Date Received
    August 13, 2008
    Report Date
    July 21, 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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BIOMED REPORTED AN UNDER INFUSION OF TPN. INFUSION WAS PROGRAMMED TO DELIVER 103ML/HR. TOTAL AMOUNT TO BE INFUSED WAS REPORTED AS 2476ML. CUSTOMER REPORTED 547ML INFUSED AFTER 6 HOURS AND 946ML INFUSED AFTER 12 HOURS. CUSTOMER REPORTS A DIFFERENCE OF 250ML UNDERINFUSED. NO PATIENT HARM AND NO MEDICAL INTERVENTION. IF DEVICE RECEIVED, INVESTIGATION WILL BE PERFORMED. A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SYSTEM FRN-INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 7130 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other