BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS PUMP

    MDR report key: 1904311 · Received November 5, 2010

    Report

    Report Number
    1904311
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    SMITHS MEDICAL NORTH AMERICA
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PCA HOOKED UP AND PROGRAMMED CORRECTLY. PT KEPT PRESSING THE BLUE BUTTON AND NOT RECEIVING MEDICATION. GREEN BLINKING LIGHT WAS NEVER ON. INNER PRONGS BENT. PRONGS ARE VERY SMALL. NEEDED FLASHLIGHT TO VIEW CROOKED PRONGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD SOLIS PUMP CADD SOLIS PUMP MEA SMITHS MEDICAL NORTH AMERICA CN40780 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR