BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY PUMP

    MDR report key: 13660543 · Received March 2, 2022

    Report

    Report Number
    MW5107858
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    December 9, 2021
    Report Date
    December 9, 2021
    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

    INBOUND. PATIENT REPORTS BOTH PUMPS ALARMING NO DISPOSABLE CLAMP TUBING LOT NUMBER 4192062, NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631633 LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.
    2631634 LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.
    2631635 CADD CASSSESTTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192062

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male