BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-MS 3 AMBULATORY INFUSION PUMP

    MDR report key: 7660547 · Received July 3, 2018

    Report

    Report Number
    3012307300-2018-02505
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Report Date
    July 3, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A TUBE BLOCKAGE OCCURRED TO A CADD MS3 PUMP. DOSE OR AMOUNT: REMODULIN 81 NKM, FREQUENCY: CONTINUOUS, ROUTE: IV. DATES OF USE: (B)(6) 2014 TO ONGOING. DIAGNOSIS OR REASON FOR USE: PAH. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501315 CADD-MS 3 AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 7400 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR