BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 121 INFUSION PUMP

    MDR report key: 9891048 · Received March 27, 2020

    Report

    Report Number
    3006967710-2020-00002
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 27, 2020
    Manufacturer
    CME AMERICA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CME AMERICA'S BODYGUARD 121 INFUSION PUMP IS CLASSIFIED AS FRN BY THE FDA, WHICH IS NOT FOR LIFE-SUSTAINING MEDICATIONS. CME AMERICA'S INSTRUCTIONS FOR USE CLEARLY STATE, "THE BODYGUARD 121 INFUSION PUMP SYSTEM SHOULD NOT BE USED TO INFUSE LIFE SUSTAINING MEDICATIONS WHOSE STOPPAGE OR INTERRUPTION COULD CAUSE SERIOUS INJURY OR DEATH." THE CUSTOMER USED THE DEVICE OFF LABEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT WHEN THE USER WAS TITRATING CHANNEL 1 FROM 0.3 MCG/KG/MIN TO 0.35 MCG/KG/MIN, CHANNEL 2 AUTOMATICALLY TITRATED TO THE SAME RATE (15ML/HR TO 105ML/HR). CHANNEL 2 WAS RUNNING AT 0.04 UNITS/HR, AND THE USER WAS UNABLE TO SWITCH CHANNELS USING THE CHANNEL SELECT BUTTON. THE CREW WAS ABLE TO IMMEDIATELY SWITCH TO ANOTHER AVAILABLE PUMP. THERE WAS NO HARM TO THE PATIENT. A CME AMERICA INTERNAL CLINICIAN MARKED THE MEDICATION USED AS FOR CRITICAL USE. ACCORDING TO THE BODYGUARD 121 OPERATOR'S MANUAL, THE USE OF VASOPRESSIN IS AN OFF LABEL USE OF THE DEVICE. SEE CHAPTER 3 UNDER GENERAL WARNINGS: "THE BODYGUARD 121 INFUSION PUMP SYSTEM SHOULD NOT BE USED TO INFUSE BLOOD, BLOOD PRODUCTS, OR LIFE-SUSTAINING MEDICATIONS WHOSE STOPPAGE OR INTERRUPTION COULD CAUSE SERIOUS INJURY OR DEATH." THE CUSTOMER USED THE DEVICE OFF LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355311 BODYGUARD 121 INFUSION PUMP BG 121 PUMP FRN CME AMERICA LLC 100-105TSA

    Patients

    Seq Age Sex Outcome Treatment
    1