BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I FLOW HOMEPUMP ECLIPSE

    MDR report key: 1352014 · Received March 25, 2009

    Report

    Report Number
    MW5010480
    Event Type
    Malfunction
    Date Received
    March 25, 2009
    Date of Event
    March 18, 2009
    Report Date
    March 25, 2009
    Manufacturer
    I FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE DISPENSED VANCOMYCIN 1GM/250CC NS IN A 250/175 I FLOW HOMEPUMP ECLIPSE PUMP LOT# 892308 EXP 02/11. PATIENT REPORTED THAT MEDICINE INFUSED IN 45 MINUTES INSTEAD OF 1 1/2 HOURS. I TESTED ANOTHER PUMP IN OUR OFFICE AND IT COMPLETED INFUSION IN 55 MINUTES. NO HARM RESULTED FROM THIS PUMP MALFUNCTION. DATS OF USE: 2009. DIAGNOSIS: PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I FLOW HOMEPUMP ECLIPSE HOMEPUMP ECLIPS MEB I FLOW CORPORATION 250/175 892308

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR