BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24219688 · Received January 30, 2026

    Report

    Report Number
    2016493-2026-03128
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 21, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    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

    THE ACTUAL DATE OF EVENT IS UNKNOWN. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT DEVICE HAD ERROR CODE 242.4030 WAS NOT DETERMINED BECAUSE NO PRODUCT OR DEVICE LOGS WERE RETURNED. 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 DEVICE SHOWED UP IN MSJ SHOP BROKEN ERROR CODE 242.4030, REPLACED AIL, & IUI CONNECTORS. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282585 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown