BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 14429543 · Received May 18, 2022

    Report

    Report Number
    2016493-2022-144548
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 14, 2022
    Report Date
    June 2, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION 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. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS STARTED ON A REMIFENTANIL INFUSION. THE CONCENTRATION WAS 5MG IN 100 ML AT 0.1 MCG/KG/MIN (11.2 G/HR AS PER PATIENT'S BODY WEIGHT). IT WAS NOTED THAT SUDDENLY, THE PATIENT'S NIBP READ MAP 55. NIBP WAS REPEATED AND SBP WAS IN THE MID 50S- 60S. PROPOFOL WAS TURNED OFF, AND LEVOPHED WAS INCREASED TO 20 MCG/MIN. THE PRIMARY RN NOTED THAT REMIFENTANIL BAG WAS EMPTY WITHIN 10 MINUTES OF BEING STARTED. THE PUMP WAS CHECKED FOR CORRECT PROGRAMMING WITH TWO OTHER RNS AND EVERYTHING WAS PROGRAMMED CORRECTLY. THERE WAS PATIENT INVOLVEMENT AND THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND REQUIRED LEVOPHED INFUSION TO BE DOUBLED IN DOSE FROM 10 MCG/MIN TO 20 MCG/MIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS STARTED ON A REMIFENTANIL INFUSION. THE CONCENTRATION WAS 5MG IN 100 ML AT 0.1 MCG/KG/MIN (11.2 G/HR AS PER PATIENT'S BODY WEIGHT). IT WAS NOTED THAT SUDDENLY, THE PATIENT'S NIBP READ MAP 55. NIBP WAS REPEATED AND SBP WAS IN THE MID 50S- 60S. PROPOFOL WAS TURNED OFF, AND LEVOPHED WAS INCREASED TO 20 MCG/MIN. THE PRIMARY RN NOTED THAT REMIFENTANIL BAG WAS EMPTY WITHIN 10 MINUTES OF BEING STARTED. THE PUMP WAS CHECKED FOR CORRECT PROGRAMMING WITH TWO OTHER RNS AND EVERYTHING WAS PROGRAMMED CORRECTLY. THERE WAS PATIENT INVOLVEMENT AND THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND REQUIRED LEVOPHED INFUSION TO BE DOUBLED IN DOSE FROM 10 MCG/MIN TO 20 MCG/MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762853 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 8015| 8100(3)