BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTA-MIX 2400

    MDR report key: 1719489 · Received May 6, 2010

    Report

    Report Number
    1419106-2010-00008
    Event Type
    Other
    Date Received
    May 6, 2010
    Date of Event
    February 26, 2010
    Report Date
    April 9, 2010
    Manufacturer
    BAXA CORP.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EM2400 COMPOUNDER IS DESIGNED TO NOT BE CONNECTED DIRECTLY TO THE FACILITY NETWORK, BUT SHOULD BE INSTALLED BEHIND A FIREWALL THAT PROVIDES A PROTECTED SUBNET FOR THE DEVICE. THE DEVICE SHOULD BE USED ONLY IN ACCORDANCE WITH ITS INTENDED USE AND NOT FOR EMAIL, INTERNET ACCESS, FILE SHARING OR OTHER NON-APPROVED USE. THE DEVICE IS DESIGNED TO ONLY REACH OUT TO THE FACILITY'S NETWORK TO COLLECT TEXT-BASED PAT FILES, BACK UP DEVICE DATABASES OR TO ISSUE A PRINT JOB. THE EM2400 COMPOUNDER IS HOSTED ON A (B)(4)-BASED EMBEDDED OPERATING SYSTEM AND HAS BEEN VERIFIED AND VALIDATED ONLY WITH THE SOFTWARE, OPERATING SYSTEM AND PATCHES THAT WERE INSTALLED BY BAXA. THUS, ANY CHANGES TO THE ORIGINAL, VALIDATED IMAGE, INCLUDING INSTALLATION OF ANTIVIRUS SOFTWARE, NULLIFIES THE VALIDATED STATE AND COULD; THEREFORE, CONSTITUTE OFF-LABEL USE OF THIS DEVICE. IN ADDITION, BAXA DOES NOT REGULARLY INSTALL OPERATING SYSTEM UPDATES OR PATCHES, GENERALLY PUBLISHED BY (B)(4), ON THIS DEVICE. THE ONLINE HELP FILE, PREVENTING CYBER ATTACKS TECHNICAL PAPER, SPECIFIES BAXA'S POLICIES RELATING TO PRODUCT SECURITY AND PROVIDES INSTRUCTIONS FOR SAFEGUARDING BAXA DEVICES. IF A DEVICE BECOMES INFECTED, BAXA TECHNICAL SUPPORT WILL SEND A REPLACEMENT AND ASSIST THE CUSTOMER WITH PROPER FACILITY NETWORK INSTALLATION. BAXA HAS NOT RECEIVED ANY REPORTS OF PT INJURY OR ILLNESS AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 1

    BAXA RECEIVED A LETTER FROM THE FDA ON 04/08/2010 IN REFERENCE TO REPORT NUMBER MW5014956. THE REPORT STATES THAT AN EM2400 COMPOUNDER WAS INFECTED WITH A VIRUS. THE CUSTOMER REQUESTED THAT BAXA PROVIDE A (B)(4) SECURITY PATCH TO PREVENT THE INFECTION FROM OCCURRING AGAIN. UPON RECEIPT OF THE MW LETTER, THE COMPLAINT DATABASE WAS REVIEWED TO DETERMINE IF AN ASSOCIATED COMPLAINT WAS RECEIVED BY BAXA PRIOR TO THIS REPORT. NO PRIOR COMPLAINT WAS FOUND. THEREFORE, A COMPLAINT WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. THIS MDR IS BEING FILED PER BAXA CORPORATION'S PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 EXACTA-MIX 2400 NEP BAXA CORP. EM 2400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA