BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SETS

    MDR report key: 9630449 · Received January 26, 2020

    Report

    Report Number
    3012307300-2020-00714
    Event Type
    Malfunction
    Date Received
    January 26, 2020
    Report Date
    January 24, 2020
    Manufacturer
    SMITHS MEDICAL ASD,INC
    Product Code
    FPA
    UDI-DI
    10610586027468
    PMA / PMN Number
    K031361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A PATIENT THAT USES SMITH MEDICAL CADD ADMINISTRATION SETS - FLOW STOP THE PRODUCT IS UNDERINFUSING LEAVING UNKNOWN MEDICATION IN THE BAG. THE AMOUNTS RANGE FROM 100-600 MILLILITERS AND EVENT HAS OCCURED WITH 30 SETS. THE PATIENT REPORTS RECEIVING REGULAR INFUSIONS AND HAS HAD NO PROBLEMS UNTIL THE GREEN TAB APPEARED ON THE TUBING. PATIENT IS MORE CONCERNED ABOUT THE COST AFFECT RELATED TO THIS ADVERSE EVENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93686 CADD ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD,INC SET, ADMIN, HIGH VOL, 1.2 FLTR, FS, TOTM 15/BX 3823339 10610586027468

    Patients

    Seq Age Sex Outcome Treatment
    1