BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES

    MDR report key: 1574856 · Received January 6, 2010

    Report

    Report Number
    MW5014254
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 6, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS CONNECTED TO HIS 5FU CHEMO -3680 MG OVER 46 HOURS VIA I-FLOW HOMEPUMP -SERIES- IN 2009 AT 12:30 PM WITHOUT INCIDENT. RN WENT TO DISCONNECT PT AT 10:30 AM TWO DAYS LATER, AT PT'S HOME FOUND THAT BALL STILL HAD QUITE A LOT STILL IN THE BALL ABOUT 40-50 CC. IMPLANTED PORT CHECKED AND FLUSHED EASILY WITH GOOD BLOOD RETURN. PUMP APPEARED TO BE INFUSING. RN WENT BACK AT 16:30 PM THE SAME DAY TO DISCONNECT PT. PT ADAMANT THAT HE BE DISCONNECTED, AND THERE WAS STILL ABOUT 20 CC LEFT IN THE BALL. MD OFFICES NOTIFIED BY RN AT TIME OF DISCONNECT. TOTAL VOLUME IN PUMP WAS 230 ML. DATES OF USE: 52 HOURS. DIAGNOSIS OR REASON FOR USE: COLON CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP C-SERIES HOMEPUMP MEB I-FLOW CORPORATION C270050 952418

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR