BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MS3 PUMPS

    MDR report key: 10463820 · Received August 27, 2020

    Report

    Report Number
    3012307300-2020-06904
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Report Date
    August 27, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD MS3 PUMPS LOST PROGRAMING. THE PATIENT REPORTED TIREDNESS, HEADACHES, NAUSEA, PAIN AND EDEMA. REPORTED THAT THE PATIENT CURRENT DOSE IS 8 NG/KG/MIN (REMDODULIN MDV, STRENGTH: 5MG/ML). NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926337 CADD MS3 PUMPS PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 7400 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1