BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23299545 · Received October 15, 2025

    Report

    Report Number
    2016493-2025-122850
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 29, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: DISREGARD THE INITIAL REPORT MFR REPORT # 2016493-2025-122850. AFTER FURTHER REVIEW OF THE FILE IT WAS DETERMINED THAT THIS FILE IS NOT A REPORTABLE COMPLAINT AND THE MDR WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD SEAR ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD SEAR ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358587 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown