BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXA EM2400 COMPOUNDER

    MDR report key: 1621627 · Received February 26, 2010

    Report

    Report Number
    MW5014956
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Report Date
    February 26, 2010
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE (B) (6) PHARMACY DEPARTMENT USES A BAXA EM2400 COMPOUNDER TO MAKE TPN'S AND OTHER ADMIXTURES. RECENTLY, THE COMPOUNDER WAS INFECTED WITH A VIRUS. THE VIRUS HAS BEEN CONTAINED ON THE EM2400 COMPOUNDER. IT IS UNKNOWN WHAT EFFECT THIS VIRUS SHOULD HAVE ON THE OPERATING OF THE SOFTWARE. (B) (6) INFORMATION SYSTEMS DEPARTMENT TOGETHER WITH THE PHARMACY HAS REQUESTED THAT BAXA PROVIDE A MICROSOFT SECURITY PATCH TO PREVENT THIS INFECTION FROM OCCURRING AGAIN. BAXA IS UNWILLING TO ALLOW THESE PATCHES TO BE APPLIED TO THE BAXA EM2400. INSTEAD BAXA HAS RECOMMEND THAT WE PLACE A ROUTER WITH THE FUNCTIONALITY FOR A FIREWALL BETWEEN THE COMPOUNDER AND THE NETWORK (B) (4) AS PROTECTION. IN A SINGLE CASE, THIS MAY BE A POSSIBLE SOLUTION. (B) (6)'S MANAGER INDICATES THAT IF THIS WAS THE ROUTINE SOLUTION, (B) (6) WOULD THEN HAVE TO PROCURE AND MAINTAIN OVER 1000 ROUTERS INSTITUTION WIDE. THAT APPROACH IS NOT SUSTAINABLE BY (B) (6) NOR THE MARKETPLACE. I AM INTERESTED TO HEAR ABOUT FDA'S REQUIREMENT FOR MEDICAL DEVICES TO HAVE SECURITY PATCHES THAT PROTECT THE DEVICE FROM CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXA EM2400 COMPOUNDER BAXA EM2400 COMPOUNDER NEP BAXA CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *