BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY PUMP

    MDR report key: 14136629 · Received April 15, 2022

    Report

    Report Number
    MW5109047
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    April 3, 2022
    Report Date
    April 3, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OUTBOUND. PT STATES HAS UNRESOLVABLE CADD LEGACY 6400 NO DISPOSABLE PUMP ALARM USING CASSETTE LOT NUMBER 4220003, EXPIRATION 11/24/2026, CADD LEGACY PUMP SERIAL NUMBER (B)(4). PUMP REPLACEMENT SENT. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2641283 LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.
    2641284 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4220003

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female