BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CME BODYGUARD 121 INFUSION PUMP

    MDR report key: 8927072 · Received August 22, 2019

    Report

    Report Number
    MW5089267
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    July 12, 2019
    Report Date
    August 20, 2019
    Manufacturer
    CME AMERICA, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FAILURE OF AN IV PUMP ON A PT RESULTING IN TEMPORARY HYPOTENSION. BODYGUARD 121 IV PUMP BEGAN ALARMING "RESTART PUMP" AND WOULD NOT PROVIDE ANY INFUSION; IV PUMP HAD TO BE TURNED OFF AND BACK ON. ONCE RESTARTED, USING THE PREVIOUS SETTINGS, IT IMMEDIATELY GAVE THE SAME ALARM. IV TUBING WAS SWITCHED TO THE SECOND CHANNEL AND STARTED. THE SECOND CHANNEL ALMOST IMMEDIATELY BEGAN ALARMING "RESTART PUMP" AGAIN. AFTER RESTARTING THE PUMP A THIRD TIME, WE HAD NO FURTHER ISSUES WITH THE PUMP DURING TRANSPORT. DURING THIS TIME, THE PT BECAME HYPOTENSIVE, AND BLOOD PRESSURE STABILITY WAS LOST, LEVOPHED INFUSION WAS RUNNING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717703 CME BODYGUARD 121 INFUSION PUMP PUMP, INFUSION FRN CME AMERICA, INC. BODYGUARD 121

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other