BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 15400924 · Received September 12, 2022

    Report

    Report Number
    2016493-2022-191528
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    August 18, 2022
    Report Date
    November 15, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    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

    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.

    Additional Manufacturer Narrative · 0

    CORRECTION : CONCOMITANT MED PROD DATA, ANNEX B : B21. ANNEX C : C21. ANNEX D : D16. ADDITIONAL INFORMATION : DEVICE EVAL BY MANUFACTURER, ANNEX A : A23, A24, A090202, ANNEX G : G0200802, G07001, G05005, ANNEX B : B01, ANNEX C : C23, C19, C02, ANNEX D : D11, D14, D02. 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 : SEE MANUFACTURER NARRATIVE.

    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. "

    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
    1805968 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention 8015.