BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC

    MDR report key: 1845004 · Received September 22, 2010

    Report

    Report Number
    MW5017564
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SALINE SOLUTION "MAY" HAVE DRIPPED FROM A PUNCTURED BAG ONTO THE IV PUMP AND BETWEEN THE MAIN UNIT AND A MODULE ATTACHED ON THE SIDE OF THE PUMP LEADING TO SMOKE AND SMALL FLAME, REQUIRING THE STAFF TO DISCONNECT THE UNIT FROM THE PT AND RECONNECT ANOTHER UNIT TO THE PT. NO HARM OR DELAY IN TREATMENT RESULTED FOR THE PT. DATES OF USE: (B)(6)2010 - (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC IV PUMP FRN CARDINAL HEALTH 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability