BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 5593453 · Received April 18, 2016

    Report

    Report Number
    MW5061814
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    April 6, 2016
    Report Date
    April 18, 2016
    Manufacturer
    SMITHS MEDICL ASB, INC.
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED FLUOROURACIL VIA CADD-LEGACY MEDICATION CASSETTE RESERVOIR (REF: (B)(4), LOT: 16X041). OTHER LOT NUMBERS THAT COULD BE AFFECTED 16X028, 15X549, 15X470. THERE WERE 2.9 ML REMAINING IN THE CASSETTE WHEN PUMP ALARMED AIR IN LINE. THIS PREVENTED THE PUMP FROM DELIVERY THE REMAINING DRUG AMOUNT DESPITE NO ERROR IN LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240529 CADD MEDICATION CASSETTE CADD MEDICATION CASSETTE FPA SMITHS MEDICL ASB, INC. 21-7002-24 16X041
    240530 CADD MEDICATION CASSETTE CADD MEDICATION CASSETTE FPA SMITH MEDICL ASB, INC. 21-7002-24 16X028
    240531 CADD MEDICATION CASSETTE CADD MEDICATION CASSETTE FPA SMITH MEDICL ASB, INC. 21-7002-24 15X549
    240532 CADD MEDICATION CASSETTE```````````````````````````````````````````````````````` CADD MEDICATION CASSETTE FPA SMITH MEDICAL ASB, INC. 21-7002-24 15X470

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention