BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 2232920 · Received July 21, 2011

    Report

    Report Number
    2183502-2011-00548
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 20, 2011
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    MEA
    PMA / PMN Number
    K072144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED FOR EVALUATION. ONCE THE DEVICE HAS BEEN EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    REPORT STATES THAT A CADD SOLIS PUMP WAS SET UP FOR PCA. USER FACILITY REPORTED THAT THE DEVICE WAS NOT DELIVERING MEDICATION. NO PUMP ALARMS OR ALERTS REPORTED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD SOLIS AMBULATORY INFUSION PUMP MEA - PUMP, INFUSION, PCA MEA SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 2100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK