BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 15875375 · Received November 28, 2022

    Report

    Report Number
    2016493-2022-231681
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    August 18, 2022
    Report Date
    November 15, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801549
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 OF THIS MDR REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OVER INFUSION OF INSULIN. A BAG OF INSULIN (100 UNITS IN 100ML) WAS INTENDED TO INFUSE AT A RATE OF 6ML/HOUR. HOWEVER, THE INFUSION WAS COMPLETED IN 28 MINUTES. FOLLOWING THE EVENT, THE PATIENT'S BLOOD GLUCOSE FELL SIGNIFICANTLY ("LESS THAN 200 POINTS IN LESS THAN 20 MINUTES") AND THE PATIENT "REQUIRED INTERVENTION WITH D50" (DEXTROSE 50%). ADDITIONALLY, THE PATIENT REQUIRED "MANAGEMENT OF POTASSIUM AND GLUCOSE LEVELS THROUGH IV MAINTENANCE" AND WAS TRANSFERRED TO A HIGHER LEVEL OF CARE (INTENSIVE CARE UNIT). ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE HAD "ERROR CODE 13-1033-149. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672060 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801549

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention 8100 (3)