BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE HOMEPUMP C-SERIES

    MDR report key: 766822 · Received September 28, 2006

    Report

    Report Number
    2026095-2006-00065
    Event Type
    Death
    Date Received
    September 28, 2006
    Date of Event
    May 18, 2005
    Report Date
    September 26, 2006
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 31, 2006, I-FLOW CORPORATION WAS NOTIFIED BY THE REPRESENTATIVE OF THE PATIENT OF A DEATH THAT OCCURRED IN 2005, DUE TO THE INCORRECT INFUSION PUMP BEING ISSUED TO THE PATIENT BY THE PHARMACY IN ERROR. AS STATED IN SECTION 'B.5' (PAGE 1) OF THE MEDWATCH FORM (3500A) AND REPORTED BY THE PATIENT'S REPRESENTATIVE, THE PATIENT WAS GIVEN A 100 ML X 100 ML/HR PUMP INSTEAD OF THE INTENDED PUMP, 125 ML X 5 ML/HR. THE ANALYSIS OF THIS EVENT BY I-FLOW IS AS FOLLOWS: THE TWO (2) DEVICES MENTIONED ARE WELL IDENTIFIED WITH SEVERAL LABELS AS TO THE VOLUME AND FLOW RATE. THE FLOW RATE LABELS ARE SPECIFICALLY COLOR-CODED. THIS MDR IS REPORTING THIS INCIDENT AS AN ERROR CAUSED BY THE END USER. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE FACILITY INTENDED TO USE A HOMEPUMP ECLIPSE C-SERIES 125 ML VOL X 5 ML/HR DEVICE TO DELIVER 5FU. INSTEAD, A 100 ML X 100 ML/HR PUMP WAS USED RESULTING IN A DELIVERY RATE 25 TIMES MORE THAN THE INTENDED RATE. THE PATIENT DIED IN 2005, REPORTEDLY FROM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE HOMEPUMP C-SERIES INFUSION PUMP MEB I-FLOW CORP. E101000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death