BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16318549 · Received February 8, 2023

    Report

    Report Number
    2016493-2023-108283
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 12, 2023
    Report Date
    April 18, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    OMIT : C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION : REPORT SOURCE. ADDITIONAL INFORMATION : IMDRF ANNEX A, G, B, C, D CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PRODUCT TESTING PERFORMED BY BD ON ALARIS SYSTEM MANAGER, IT WAS FOUND THAT THE APPLICATION TEMPORARILY STORES CREDENTIALS IN MEMORY AS PLAIN TEXT. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A PRODUCT TESTING PERFORMED BY BD ON ALARIS SYSTEM MANAGER, IT WAS FOUND THAT THE APPLICATION TEMPORARILY STORES CREDENTIALS IN MEMORY AS PLAIN TEXT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250531 ALARIS SYSTEM SERVER, INFUSION FRN CAREFUSION SD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown