BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1241534 · Received November 21, 2008

    Report

    Report Number
    2016493-2008-00184
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    KO12383
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 11/19/2008.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THREE (3) ERROR MESSAGES WHILE PATIENT WAS BEING RESUSCITATED. CUSTOMER REQUESTED EVENT LOG REVIEW. WHEN THE FIRST LVP WAS ADDED FOR CALCIUM CHLORIDE INFUSION IT "SHUT DOWN". WHEN THE SECOND LVP WAS ADDED FOR A NORMAL SALINE (NS) INFUSION, IT "SHUT DOWN". THE THIRD LVP WAS ADDED AND THE "WHOLE SYSTEM" WENT DOWN. ULTIMATELY THE PATIENT EXPIRED, HOWEVER, CUSTOMER REPORTS THE "SHUT DOWN" WAS NOT THE CAUSITIVE FACTOR. INVESTIGATION IS ON-GOING. FOLLOW UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION SYSTEM FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening