BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 3843575 · Received May 21, 2014

    Report

    Report Number
    2016493-2014-00242
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VISUALIZING SMOKE FROM THE RIGHT SIDE OF THE PCU DURING INFUSION. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO FURTHER EVENT OR PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303982 ALARIS PC UNIT FRN CARDINAL HEALTH 303, INC. 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PUMP MODULE, SN (B)(4),| ALARIS AUTO-ID MODULE, SN (B)(4),