BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B BRAUN

    MDR report key: 1972580 · Received January 24, 2011

    Report

    Report Number
    MW5019124
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    November 4, 2010
    Report Date
    January 17, 2011
    Manufacturer
    B BRAUN MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BROKEN RUNAWAY PROTECTION ON B BRAUN INFUSOMAT SPACE INFUSION PUMP. BEGINNING ON (B)(6), 2010 AND CONTINUING THROUGH (B)(6), 2011, THE HOSPITAL HAS EXPERIENCED FOUR BROKEN RUNAWAY PROTECTION PARTS ON THE B BRAUN INFUSOMAT SPACE. WITH THIS PART BROKEN, A FREE FLOW COULD OCCUR IF THE END USER DOES NOT ENSURE THE ROLLER CLAMP IS CLOSED. THIS POTENTIAL IS CONCERNING TO THE HOSPITAL. UNITS REPORTING PROBLEM WERE CVICU & MICU, TWO OTHERS WERE FOUND WHILE PERFORMING PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B BRAUN INFUSION PUMP FRN B BRAUN MEDICAL 8713050U INFUSOMAT SPACE

    Patients

    Seq Age Sex Outcome Treatment
    1