BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 121 INFUSION PUMP

    MDR report key: 6614687 · Received June 6, 2017

    Report

    Report Number
    3006967710-2017-00003
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Report Date
    May 16, 2017
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    CUSTOMER SAID THE PUMP STOPPED INFUSING DURING A PATIENT TRANSPORT. THE ATTENDING NURSE HAD TO MANUALLY ADMINISTER THE MEDICATION AFTER A TWO-MINUTE DELAY TO TROUBLESHOOT THE PUMP. THE RN STATED THERE WAS NO HARM TO THE PATIENT, BUT IF THE EVENT WERE TO RECUR IT IS POSSIBLE THERE COULD BE PATIENT HARM. THE DEVICE WAS BEING USED TO ADMINISTER CRITICAL MEDICATION AT THE TIME THE PUMP STOPPED INFUSING. CME AMERICA'S INSTRUCTIONS FOR USE (IFU) STATES "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." THIS DEVICE WAS BEING USED OFF-LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394597 BODYGUARD 121 INFUSION PUMP BG 121 PUMP FRN CME AMERICA, LLC 100-105TSA

    Patients

    Seq Age Sex Outcome Treatment
    1