BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 13479456 · Received February 8, 2022

    Report

    Report Number
    3012307300-2022-02861
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Report Date
    February 8, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    END USER REPORTED ?LIGHTHEADED". ADDITIONAL CONTACT INFORMATION: (B)(6). NAME OF PERSON COMPLETING FORM: (B)(6).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD LEGACY PLUS, MDL 6500, PUMP EXHIBITED HIGH PRESSURE ALARMING FOR THE LAST THREE HOURS AND THE END USER WAS LIGHTHEADED. IT WAS REPORTED THE END USER SWITCHED OUT THE PUMP AND THE CASSETTE WAS WORKING. PER REPORTER THE BACKUP PUMP BUTTONS WERE HARD TO PUSH. MEDICATION: REMODULIN 1MG.ML, (B)(4). DOSE: 13 NG/KG/MIN - INTRAVENOUS. FREQUENCY: CONTINUES. START DATE: (B)(6) 2021. LOT 2101977, EXPIRATION DATE 01/31/2023. DIAGNOSIS: PULMONARY ARTERIAL HYPERTENSION (PAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594883 CADD-LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Female