BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24854142 · Received April 13, 2026

    Report

    Report Number
    2016493-2026-20629
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 2, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT DEVICE HAD FAILED CALIBRATION 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 APPROXIMATELY 40 LARGE VOLUME PUMP MODULES WERE FAILING RATE ACCURACY AND REQUIRED CALIBRATION. BD TPC DISCUSSED WHETHER THEY WERE USING THE 8100 RCS ADMINISTRATION SET FOR PERFORMING RATE ACCURACY IN THE PM TASK IN THEIR ALARIS SYSTEM MAINTENANCE SOFTWARE. CUSTOMER ADVISED THEY HAD BEEN USING THE 8100 RCS ADMINISTRATION SET BUT IT WAS AGREED THAT THEY SHOULD ORDER A NEW ONE AND SEE IF THAT WILL REDUCE THE NUMBER OF DEVICES NEEDING CALIBRATION. CUSTOMER ADVISED THEY WILL UPDATE AFTER THEY BEGIN TESTING AGAIN AFTER RECEIVING THE NEW 8100 RCS ADMINISTRATION TEST SETS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923125 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015