BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18391391 · Received December 26, 2023

    Report

    Report Number
    2016493-2023-251433
    Event Type
    Malfunction
    Date Received
    December 26, 2023
    Date of Event
    November 19, 2023
    Report Date
    February 14, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.

    Additional Manufacturer Narrative · 0

    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 AT APPROXIMATELY 2100, THE REGISTERED NURSE PROGRAMMED THE PUMP MODULE TO INFUSE A SECONDARY MEDICATION OF POTASSIUM PHOSPHATE WITH A CONCENTRATION OF 5MMOL/50ML. THE INFUSION WAS SET FOR 8.612 ML/HR WITH A VOLUME TO BE INFUSED OF 51.67ML. THE NURSE REALIZED THAT THE BAG WAS EMPTY AND THE ENTIRE MEDICATION HAD INFUSED IN LESS THAN FIVE MINUTES. IT WAS ALSO MENTIONED THAT PRIOR TO THE EVENT, "D5NS+20MEQ" OF POTASSIUM CHLORIDE WAS RUNNING AT 60 ML/HR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT APPROXIMATELY 2100, THE REGISTERED NURSE PROGRAMMED THE PUMP MODULE TO INFUSE A SECONDARY MEDICATION OF POTASSIUM PHOSPHATE WITH A CONCENTRATION OF 5MMOL/50ML. THE INFUSION WAS SET FOR 8.612 ML/HR WITH A VOLUME TO BE INFUSED OF 51.67ML. THE NURSE REALIZED THAT THE BAG WAS EMPTY AND THE ENTIRE MEDICATION HAD INFUSED IN LESS THAN FIVE MINUTES. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400465 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male 8015| 8100