BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14838937 · Received June 28, 2022

    Report

    Report Number
    2016493-2022-157250
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 4, 2022
    Report Date
    June 10, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MAGNESIUM INFUSION WAS PROGRAMMED INCORRECTLY. THE INTENDED DOSE WAS 2 G/HR (50ML/HR), HOWEVER 2 ML/HR (0.8 G/HR) PROGRAMMED AND DELIVERED TO THE PATIENT FOR ABOUT 11 HOURS. THE PATIENTS BLOOD PRESSURE KEPT INCREASING AND REQUIRED ADDITIONAL ANTIHYPERTENSIVE MEDICATION. THERE WAS A PATIENT INVOLVEMENT WITH SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910766 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention