BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE

    MDR report key: 5260369 · Received November 25, 2015

    Report

    Report Number
    MW5058189
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    November 21, 2015
    Report Date
    November 25, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    HOMEPUMP ECLIPSE LOT #0202229805 I-FLOW LLC WWW.IFLO.COM TUBING BECAME DISCONNECT AT 175ML/HOUR FILTER. THIS CAUSED LEAKING OF TUBING, MEDICATION NOT BEING ADMINISTERED AND RISK FOR BLOOD STREAM INFECTION. REASON FOR USE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782343 HOMEPUMP ECLIPSE PUMP, INFUSION, ELASTOMERIC MEB HALYARD HEALTH 335ML 0202229805

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR