BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE

    MDR report key: 1934766 · Received December 13, 2010

    Report

    Report Number
    1934766
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 5, 2010
    Report Date
    December 13, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE 5FU ELASTOMERIC PUMP NOT DEFLATED AT DISCONNECT TIME. ALL CLAMPS WERE OPEN. TAKEN TO PHARMACY AND THEY VERIFIED THE PUMP DID NOT DEFLATE. ADDITIONAL CHEMOTHERAPY REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ECLIPSE PUMP, INFUSION, ELASTOMERIC MEB I-FLOW CORP. C-SERIES 270 ML, 5 ML/HR. *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR CHEMOTHERAPY