BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11904472 · Received May 28, 2021

    Report

    Report Number
    3012307300-2021-05142
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 6, 2021
    Report Date
    May 28, 2021
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED FROM (B)(6) 2021 THROUGH (B)(6) 2021 DUE TO A HICKMAN LINE INFECTION. PATIENT ALSO CAUGHT COVID-19 WHILE BEING HOSPITALIZED. DURING REPORT, PATIENT HAD BLOOD IN LINE AND THE PUMP TUBING WAS ALARMING HIGH PRESSURE WHEN HE TRIED TO FIX IT ON HIS OWN. PATIENT HAD NO REMODULIN INFUSION FOR ABOUT THREE TO FOUR HOURS. HE DENIED ANY SYMPTOMS. THE PUMP WAS LATER INFUSION AND THERE WAS NO MORE BLOOD IN THE TUBING; THE ALARM RESOLVED. (REMODULIN 5MG/ML, DOSE AND ROUTE PRESCRIBED: REMODULIN DOSE - 80 NG/KG/ M I N - INTRAVENOUS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801825 CADD INTRAVASCULAR ADMINISTRATION SET FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR