BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 25123134 · Received May 8, 2026

    Report

    Report Number
    2016493-2026-27179
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 5, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 8100 FAILED RATE ACCURACY WAS NOT IDENTIFIED DURING THE CUSTOMER CALL. CUSTOMER REPORTED USING AN 8100-RCS (RATE CALIBRATION SET) AND NOTED THAT THIS IS THE SECOND OCCURRENCE OF THE ISSUE. HE CONFIRMED PRIOR SUCCESSFUL USAGE OF THE SAME. ADVISED CUSTOMER THAT THE 8100-RCS IS RATED FOR UP TO 60 USES. RECOMMENDED REPLACING THE EXISTING 8100-RCS WITH A NEW SET TO VERIFY RATE ACCURACY. CUSTOMER WILL REPLACE THE 8100-RCS AND PERFORM TESTING. IF THE ISSUE PERSISTS AFTER REPLACEMENT, RECOMMENDED TO REPLACE MECHANISM AND BEZEL ASSEMBLY. 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 8100 FAILED RATE ACCURACY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54356 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION 303, INC. 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown