BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS PCA PUMP

    MDR report key: 1963749 · Received January 12, 2011

    Report

    Report Number
    MW5019004
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 29, 2010
    Report Date
    January 12, 2011
    Manufacturer
    SMITH MEDICAL
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CADD SOLIS PCA PUMP SHUT OFF DURING A BOLUS DOSE OF MEDICATION. NO PT INJURY. PUMP RETURNED TO (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD SOLIS PCA PUMP PCA PUMP MEA SMITH MEDICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1