BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 22628693 · Received July 28, 2025

    Report

    Report Number
    2016493-2025-100448
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 3, 2025
    Report Date
    November 20, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K031741
    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

    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. ROOT CAUSE: THE PROBABLE CAUSE OF THE DEVICE 8300 HAD ERROR 9-100-1318 WAS DUE TO WRONG VERSION INSTALLED. THE TECH SUPPORT RECOMMENDED TO INSTALL ASM VERSION 12 INSTEAD OF ASM V12.3.

    Additional Manufacturer Narrative · 0

    OMIT: A20 - INSTALLATION-RELATED PROBLEM (2965), C1603 - INSTALLATION PROBLEM IDENTIFIED, D1101 - FAILURE TO FOLLOW INSTRUCTIONS. ADDITIONAL INFORMATION: IMDRF ANNEX A ,C AND D CODES. CORRECTION: MANUFACTURER NARRATIVE. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. ROOT CAUSE: THE PROBABLE CAUSE OF THE DEVICE 8300 HAD ERROR CODE 9-100-1318 WAS DUE TO SOFTWARE INCOMPATIBILITY. TECH SUPPORT RECOMMENDED TO UPDATE ASM VERSION 12 INSTEAD OF ASM V12.3. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8300 HAD ERROR 9-100-1318. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8300 HAD ERROR 9-100-1318. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695008 ALARIS SYSTEM SERVER, INFUSION FRN CAREFUSION SD 8975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8300