BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24726784 · Received March 30, 2026

    Report

    Report Number
    2016493-2026-17045
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 16, 2026
    Report Date
    March 23, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 8100 DEVICE FAILING THE RATE CALIBRATION SET WAS NOT IDENTIFIED DURING THE CUSTOMER CALL. BIOMED WAS USING A REGULAR IV SET INSTEAD OF THE 8100 RCS RATE CALIBRATION SET. ADVISED BIOMED TO USE THE 8100 RCS WHEN PERFORMING A RATE CALIBRATION. IF THE RATE CALIBRATION CONTINUES TO FAIL AFTER USING THE CORRECT RCS, RECOMMENDED REPLACING THE BEZEL ASSEMBLY (PART# 49000437). 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 FAILS RATE CALIBRATION SET. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789358 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown