BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14943926 · Received July 7, 2022

    Report

    Report Number
    2016493-2022-159691
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 15, 2022
    Report Date
    June 15, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS ¿SSL CERTIFICATE VULNERABILITIES¿ RELATED TO ALARIS SYSTEMS MANAGER. IT WAS FOUND BY THE FACILITY¿S DIRECTORY SERVICES, IDENTITY & ACCESS MANAGEMENT, FEDERATION, PKI THAT THE ISSUE IS RELATED TO ¿SSL SELF SIGNED CERT USING SHA-1 WITH RSA ENCRYPTION.¿ THEY THEN SUGGESTED TO FIND OUT WITH BD IF THIS CERTIFICATE IS REQUIRED, TAKE PROPER ACTION, AND ¿REMOVE IT IF NOT USED.¿ BD PROVIDED ASSISTANCE TO THE CUSTOMER; THE ISSUE WAS RESOLVED BY DELETING THE CERTIFICATE IN QUESTION FROM THE SERVER. THERE WAS NO PATIENT INVOLVEMENT AND THERE WERE NO REPORTS OF ACTUAL PRODUCT SECURITY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722833 ALARIS SYSTEM SERVER, INFUSION FRN CAREFUSION SD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown