BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MS 3

    MDR report key: 10929545 · Received December 1, 2020

    Report

    Report Number
    3012307300-2020-11982
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 1, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PUMP STOPPED AT 3 IN THE MORNING AND THE PATIENT ONLY NOTICED AT 10 IN THE MORNING. THE PATIENT RESTARTED THE PUMP AT THIS TIME AND CONTINUED TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY SIDE EFFECTS DUE TO THIS ISSUE. THE THERAPY WAS AS FOLLOWS: REMODULIN MDV, STRENGTH: 10MG/ML, DOSE OR AMOUNT: 43 NG/KG/MIN, FREQUENCY: CONTINUOUS, ROUTE: SUBCUTANEOUS, PAH. NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391660 CADD MS 3 PUMP, INFUSION FRN ST PAUL 21-7411-51 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR