BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21906226 · Received April 25, 2025

    Report

    Report Number
    2016493-2025-76019
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 31, 2025
    Report Date
    June 24, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. 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: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2025-76019 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2025-76020, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER "1 BAG OF IV POTASSIUM WAS STARTED AT 1220 FOR THIS PATIENT BY RN. CHANNEL WAS PROGRAMMED AT ORDERED RATE OF5 50ML/HR. BAG WOULD RUN OVER 1 HOUR. STARTED INFUSION AND LEFT ROOM. HEARD IV PUMP ALARMING AT 1248. NOTED CHANNEL RUNNING POTASSIUM WAS ALARMING. NOTED AIR IN LINE ALARM. NOTED POTASSIUM BAG TO BE COMPLETELY EMPTY. PAUSED INFUSION AND CHECKED FOR CONFIRMATION THAT PUMP WAS PROGRAMMED CORRECTLY BY RN. IT WAS VERIFIED THAT THE PUMP WAS PROGRAMMED CORRECTLY. THE PATIENT WAS NOT INJURED. CUSTOMER IS REQUESTING A WRITTEN REPORT. CUSTOMER REPORT: SL-170348". THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER "1 BAG OF IV POTASSIUM WAS STARTED AT 1220 FOR THIS PATIENT BY RN. CHANNEL WAS PROGRAMMED AT ORDERED RATE OF5 50ML/HR. BAG WOULD RUN OVER 1 HOUR. STARTED INFUSION AND LEFT ROOM. HEARD IV PUMP ALARMING AT 1248. NOTED CHANNEL RUNNING POTASSIUM WAS ALARMING. NOTED AIR IN LINE ALARM. NOTED POTASSIUM BAG TO BE COMPLETELY EMPTY. PAUSED INFUSION AND CHECKED FOR CONFIRMATION THAT PUMP WAS PROGRAMMED CORRECTLY BY RN. IT WAS VERIFIED THAT THE PUMP WAS PROGRAMMED CORRECTLY. THE PATIENT WAS NOT INJURED. CUSTOMER IS REQUESTING A WRITTEN REPORT. CUSTOMER REPORT: (B)(6)". THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502047 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown