BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE

    MDR report key: 2261416 · Received September 15, 2011

    Report

    Report Number
    MW5022311
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    BBRAUN
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ECLIPSE ELASTOMERIC INFUSION SYSTEM 100ML/HR 100ML E101000, LOT# 952391 LEAKED AT THE TUBING HUB. DATES OF USE: (B)(6) 2011. REASON FOR USE: INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HOMEPUMP MEB BBRAUN E101000 952391

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR CEFEPIME 2GM IN 100ML 100ML/HR ECLIPSE INFUSOR.