BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH-ALARIS PRODUCTS

    MDR report key: 1172017 · Received September 22, 2008

    Report

    Report Number
    MW5008386
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    March 12, 2008
    Report Date
    September 22, 2008
    Manufacturer
    CARDINAL HEALTH - ALARIS PRODUCTS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT END OF AUTOMATIC TRANSFER SWITCH (ATS) TESTING. TWO ALARIS POINT-OF-CARE UNITS (PCUS) SHUT-DOWN. ATTACHED TO THESE TWO PCUS WERE 4 LARGE VOLUME PUMP MODULES (LVPS) AND 3 SYRINGE MODULES, SO A TOTAL OF SEVEN IV INFUSIONS WERE STOPPED. PATIENT WAS NOT HARMED, BUT THIS COULD HAVE BEEN A FATAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL HEALTH-ALARIS PRODUCTS POINT-OF-CARE UNIT FRN CARDINAL HEALTH - ALARIS PRODUCTS 8000

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening