BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FLOW HOME INFUSION PUMP

    MDR report key: 3212808 · Received July 2, 2013

    Report

    Report Number
    MW5030793
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 2, 2013
    Manufacturer
    KIMBERLY CLARK
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVES 5FU CONTINUOUSLY VIA HOME INFUSION PUMP. COMES IN ONCE A WEEK TO CHANGE PUMP, CONNECT NEW PUMP. UPON ARRIVAL TO DISCONNECT PUMP, NOTED MEDICATION DID NOT INFUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302908 I-FLOW HOME INFUSION PUMP HOME INFUSION PUMP, DISPOSABLE, NON-ELECTRIC MEB KIMBERLY CLARK 0200546562

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR