BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 3760948 · Received April 9, 2014

    Report

    Report Number
    2016493-2014-00203
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 24, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED CAREFUSION SERVICE DEPARTMENT TO RETURN A PC UNIT BECAUSE IT WAS NOT COMMUNICATING WITH OTHER DEVICES ON THE RIGHT SIDE. AFTER SPEAKING WITH THE REPAIR CENTER REPRESENTATIVE, IT WAS DETERMINED THE DEVICE WAS IN USE ON A PATIENT WHEN THE USER SAW A "FLASH AND SMOKE" FROM THE RIGHT SIDE OF THE PC UNIT. THE DEVICE HAS BEEN SEQUESTERED BY NURSING AND SENT TO BIOMED FOR REPAIR. THE BIOMED STATED HE WAS UNABLE TO REPAIR THE DEVICE AND SENT IT TO CAREFUSION SERVICE DEPARTMENT. NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213251 ALARIS PC UNIT FRN CAREFUSION CORPORATION 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PUMP MODULE ADMIN SET, MODEL/LOT UNK| ALARIS PUMP MODULE, SN UNK