BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 25093248 · Received May 6, 2026

    Report

    Report Number
    2016493-2026-26302
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 24, 2026
    Report Date
    April 30, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 PROBABLE CAUSE OF THE REPORTED DEVICE HAD ERROR 13-1033-149 WAS NOT IDENTIFIED DURING THE CUSTOMER CALL. THE CUSTOMER REPORTED THAT UPON RECEIVING THE 8100 DEVICE, THE CHANNEL DISPLAYS ERROR CODE 13?1033?149. RECOMMENDED TO RE-FLASHING 8100 MODULE. INFORMED THE CUSTOMER THAT THE PREVENTIVE MAINTENANCE TASK MAY NEED TO BE EXECUTED, TO VERIFY IF FAULT STILL PERSISTS. INFORMED THE CUSTOMER, IF THE PROBLEM PERSISTS, THEY WILL NEED TO REPAIR/REPLACE THE LOGIC BOARD. 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 HAD ERROR 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154093 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown