BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION PUMP

    MDR report key: 1062858 · Received June 11, 2008

    Report

    Report Number
    2016493-2008-00053
    Event Type
    Other
    Date Received
    June 11, 2008
    Date of Event
    July 12, 2007
    Report Date
    May 29, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    REPORTED AS AN OVER INFUSION OF INTRALIPIDS. NO PT HARM OR MEDICAL INTERVENTION REPORTED. CLINICAL BIOMED REPORTED PUMP HAS BEEN PLACED BACK INTO SVC. CUSTOMER REPORTED NO CLINICAL INFO WILL BE PROVIDED PER HOSP POLICY. SEVERAL CALLS PLACED TO RISK MGR SPECIALIST FOR CLINICAL INFO WITH NO RESPONSE BACK. THERE IS NO DEVICE HISTORY ON FILE TO INDICATE REPAIRS PERFORMED AT CARDINAL HEALTH SVC CTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS, 1325B *

    Patients

    Seq Age Sex Outcome Treatment
    1 03 DAY Other