BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 121 INFUSION PUMP

    MDR report key: 10098136 · Received May 28, 2020

    Report

    Report Number
    3006967710-2020-00005
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    April 21, 2020
    Report Date
    April 28, 2020
    Manufacturer
    CME AMERICA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER. THE INVESTIGATION BY CME AMERICA IS ON-GOING AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS, "BODYGUARD IV PUMP WAS INFUSING. SUDDENLY BEGAN TO RAPIDLY INFUSE FOR 1-3 SECONDS, STOPPED, ALARMED AND PROMPTED STAFF WITH ERROR MESSAGE TO POWER PUMP OFF AND RESTART." THERE WAS NO PATIENT HARM REPORTED. CME AMERICA IS CONDUCTING AN INVESTIGATION INTO THE OCCURRENCE AND THE CAUSE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559181 BODYGUARD 121 INFUSION PUMP BG121 FRN CME AMERICA LLC 100-105TSA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR