BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD EXT SET

    MDR report key: 12107757 · Received July 1, 2021

    Report

    Report Number
    MW5102254
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 25, 2021
    Report Date
    June 25, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL: INBOUND CALL FROM (B)(6). INQUIRING ABOUT PATIENTS DOSING INFORMATION FOR IVV. DOSE 36 NKM, PT WEIGHT: (B)(6) KG, CONCENTRATION: 60,000 NG/ML, PUMP RATE 69 ML/24 HR. PATIENT WENT INTO ER FOR LINE MALFUNCTION. MD WAS MADE AWARE. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994503 CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other