BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17727061 · Received September 12, 2023

    Report

    Report Number
    2016493-2023-226968
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 27, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    PHC
    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

    OMIT : C20 - NO FINDINGS AVAILABLE. CORRECTION : MEDICAL DEVICE TYPE. ADDITIONAL INFORMATION : IMDRF ANNEX A, G, B, C CODES.

    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. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INTERNAL SECURITY SCANNING PERFORMED ON INFUSION ADAPTER V1.7.1 APPLICATION, THERE EXISTED HARDCODED CREDENTIALS WHICH IS A SECURITY VULNERABILITY. THE VULNERABILITY WAS INVESTIGATED BY THE INFUSION ITRT GROUP AND FOUND TO BE A VALID VULNERABILITY THAT IMPACTS FIELDED VERSIONS OF ALARIS V12.3.1 AND EARLIER. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INTERNAL SECURITY SCANNING PERFORMED ON INFUSION ADAPTER V1.7.1 APPLICATION, THERE EXISTED HARDCODED CREDENTIALS WHICH IS A SECURITY VULNERABILITY. THE VULNERABILITY WAS INVESTIGATED BY THE INFUSION ITRT GROUP AND FOUND TO BE A VALID VULNERABILITY THAT IMPACTS FIELDED VERSIONS OF ALARIS V12.3.1 AND EARLIER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801952 ALARIS SYSTEM SERVER, INFUSION PHC CAREFUSION SD
    985778 ALARIS SYSTEM SERVER, INFUSION PHC CAREFUSION SD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown