BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA MEDICAL ONCOLOGY

    MDR report key: 2556124 · Received April 23, 2012

    Report

    Report Number
    2916710-2012-00018
    Event Type
    Malfunction
    Date Received
    April 23, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS REPORTED BY (B)(6) AND NO MISS-ADMINISTRATION OF MEDICATIONS HAS BEEN REPORTED BY A CUSTOMER. THE INVESTIGATION HAS IDENTIFIED A DESIGN DEFICIENCY WITHIN THE SOFTWARE. FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    DURING VARIAN'S INTERNAL TESTING, THE 3RD PARTY VENDOR, ((B)(6)) REPORTED THE NDC VALUE FOR A SELECTED DRUG CAN BE INCORRECT WHEN SENT THROUGH E-RX. THIS EVENT DID NOT INVOLVE PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA MEDICAL ONCOLOGY NONE IYE VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1