BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 121509 · Received September 19, 1997

    Report

    Report Number
    MW1012132
    Event Type
    Malfunction
    Date Received
    September 19, 1997
    Date of Event
    September 4, 1997
    Report Date
    September 8, 1997
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE BLOCK ECLIPSE HOMEPUMP LABELING AND INSTRUCTIONS DO NOT CLEARLY ALERT THE PROVIDER THAT UNDERFILLED PUMPS INFUSE AT A HIGHER RATE THAN STATED ON THE PUMP. THE INFO FOR THE HEALTHCARE PROVIDER ON THE INFO SHEET DOES NOT MENTION THE APPROX. DELIVERY TIME CHART ON THE BOTTOM OF THE PAGE. THE PACKAGE LABEL ONLY STATES A FLOW RATE AND VOLUME CAPACITY. A PT RECEIVED 6 GMS OF CYTARABINE IN 200 ML NS OVER 1 HR 15 MIN FROM AN E40100 HOMEPUMP WITH A LABELED RATE OF 100 ML/HR. DOSE WAS PREPARED APPROX 3 HRS BEFORE INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HOMEPUMP ELASTOMERIC PUMP MEB BLOCK MEDICAL, INC. E401000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other