BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21136666 · Received January 13, 2025

    Report

    Report Number
    2016493-2024-47066
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 19, 2024
    Report Date
    December 24, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CLINICIAN THAT WHEN THEY "GAVE MAGNESIUM AS AN IV PIGGYBACK THAT AFTER THE SECONDARY COMPLETED THE RATE OF THE PRIMARY FLUID COULD BE INCREASED WITHOUT THE SAME SAFETY LIMITS AS THE MAGNESIUM, EVEN THOUGH THERE WAS STILL MED IN THE LINE." THE CUSTOMER PROVIDED ADDITIONAL INFORMATION "AFTER SOME INVESTIGATING, I DO NOT THINK IT WAS AN EVENT BUT COULD HAVE BEEN A PROBLEM IF IT WAS NOT CAUGHT. THE OB STAFF WAS CONCERNED THAT THE MAGNESIUM MEDICATION THAT WAS RUNNING AS A SECONDARY BAG SWITCHED TO THE FASTER PRIMARY BAGS RATE WHEN THE VTBI WAS COMPLETED. HOWEVER, THERE WAS STILL MAGNESIUM IN THE BAG AND IT WAS NOW RUNNING TOO FAST." THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478464 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown (B)(6)