BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 23035263 · Received September 12, 2025

    Report

    Report Number
    2016493-2025-113311
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 15, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: DISREGARD THE MFR REPORT #. AFTER FURTHER REVIEW, IT WAS DETERMINED THE REPORT IS A DUPLICATE OF THE PREVIOUSLY REPORTED EVENT CAPTURED UNDER MFR REPORT #2016493-2025-113507.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A PUMP MODULE DISPLAYING A ¿CHANNEL ERROR¿. THE FACILITY ATTEMPTED TO TROUBLESHOOT THE UNIT AND STATED IT WAS A ¿PRESSURE TRANSDUCER FAILS¿. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A PUMP MODULE DISPLAYING A ¿CHANNEL ERROR¿. THE FACILITY ATTEMPTED TO TROUBLESHOOT THE UNIT AND STATED IT WAS A ¿PRESSURE TRANSDUCER FAILS¿. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305937 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015