BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MS3 7400

    MDR report key: 5466521 · Received February 24, 2016

    Report

    Report Number
    MW5060582
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 22, 2016
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CADD LEGACY SN (B)(4) IS ALARMING WITH NO MESSAGE TO RELOAD CARTRIDGE, ADVISED WILL REPLACE. DOSE OR AMOUNT: 131 NKM; FREQUENCY: CONTINUOUS; ROUTE: SQ. DATES OF USE: FROM (B)(6) 2016 TO ONGOING. DIAGNOSIS OR REASON FOR USE: I27.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113301 CADD MS3 7400 CADD MS3 7400 FRN SMITHS MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR