BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUMP

    MDR report key: 11646569 · Received April 10, 2021

    Report

    Report Number
    3012307300-2021-03027
    Event Type
    Malfunction
    Date Received
    April 10, 2021
    Report Date
    April 10, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD LEGACY PUMP OVER DELIVERY WAS NOTICED. IT WAS REPORTED THAT THE REMODULIN CASSETTE (42 NG/KG/ M I N INTRAVENOUS) WAS EMPTY BEFORE THE SCHEDULE REPLACEMENT TIME. IT WAS ALSO REPORTED THAT THE PATIENT STATED SHE HAS NOT BEEN FEELING WELL THE LAST COUPLE OF DAYS AND LOSS APPETITE AND HIGH BLOOD SUGARS AND ALLERGIES. IN ADDITIONALLY, OTHER TADALFIL, OPSUMIT WHERE ALSO USED DURING THE TIME OF THE REPORTED EVENTS. NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543977 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1