BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14273863 · Received May 4, 2022

    Report

    Report Number
    3012307300-2022-07412
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    December 27, 2021
    Report Date
    May 2, 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

    (1/2, REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING PUMP) PER MEDWATCH MW5108125: PATIENT STATED CASSETTE LOT NUMBER IS 4192062, EXPIRATION 2026/09/02, THE PUMP DISPLAYED RES VOLUME OF 32 MILLILITERS WHEN NO DISPOSABLE ALARM STARTED, NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501067 CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown