BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES

    MDR report key: 1574855 · Received January 6, 2010

    Report

    Report Number
    MW5014253
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    December 29, 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 CONNECTED TO CHEMO-2200 MG OF 5 FU OVER 46 HOURS VIA I-FLOW HOMEPUMP C-SERIES- IN 2009 AT 3:30 PM, HOOK UP WENT SMOOTHLY WITHOUT INCIDENT. PT WAS DUE TO BE DISCONNECTED TWO DAYS LATER AT 1:30 PM. THE RN NOTED THAT ONLY ABOUT 1/2 OF THE MEDICATION HAD BEEN INFUSED. IMPLANTED PORT WAS CHECKED AND FOUND TO BE PATENT. THE PUMP APPEARED TO BE INFUSING WITHOUT PROBLEM. PT WAS RECONNECTED AND PT TOLD TO CALL WHEN INFUSION COMPLETE. PT INFUSED FOR A TOTAL OF 70 HOURS INSTEAD OF 46 HOURS. TOTAL VOLUME IN PUMP WAS 230 ML. DATES OF USE: 70 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