BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14408735 · Received May 16, 2022

    Report

    Report Number
    3012307300-2022-08881
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    January 6, 2022
    Report Date
    May 16, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (2/2 REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING PUMP) PER MEDWATCH MW5108069: INBOUND. NO DISPOSABLE PUMP ALARM USING 100ML CASSETTE FROM LOT 4173645 EXPIRATION 08/19/2026. REPLACEMENT PUMP SENT. NO FURTHER DETAILS PROVIDED. MEDWATCH REPORT MW5108074 RECEIVED 20/APR/2022. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030841 CADD PUMP,INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown