BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17057935 · Received June 5, 2023

    Report

    Report Number
    2016493-2023-175930
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    April 1, 2023
    Report Date
    August 28, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 2016493-2023-175930 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-222786, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Additional Manufacturer Narrative · 0

    PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 4/1/23 AROUND 23:50 THE DEVICE SHUTDOWN UNEXPECTEDLY WHILE INFUSING EPINEPHRINE, VASOPRESSIN AND INSULIN DRIPS WITHOUT WARNING AND WOULD NOT POWER BACK ON. THERE WAS PATIENT INVOLVEMENT BUT HARM IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 AROUND 23:50 THE DEVICE SHUTDOWN UNEXPECTEDLY WHILE INFUSING EPINEPHRINE, VASOPRESSIN AND INSULIN DRIPS WITHOUT WARNING AND WOULD NOT POWER BACK ON. THERE WAS PATIENT INVOLVEMENT BUT HARM IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463206 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown