BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS GEMINI INFUSION SYSTEM

    MDR report key: 1172681 · Received September 10, 2008

    Report

    Report Number
    2016493-2008-00141
    Event Type
    Other
    Date Received
    September 10, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 27, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    REPORTER CALLED TO REPORT A PT INCIDENT AT THE HOSPITAL. RISK MANAGER, REPORTED PHOSPHOLIPIDS INFUSING ON A PT. USER REPORTED DEVICE PROGRAMMED CORRECTLY, AND INFUSED FASTER THAN THE ALLOTTED TIME. NO PT HARM OR MEDICAL INTERVENTION REQUIRED. RISK MANAGER WOULD NOT PROVIDE ANY OTHER DETAILS. REQUESTED DEVICE FOR FAILURE INVESTIGATION. IF DEVICE RECEIVED AND WHEN INVESTIGATION COMPLETED, WILL SEND A F/U REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS GEMINI INFUSION SYSTEM GEMINI INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 1325D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other