BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY PUMP

    MDR report key: 13660491 · Received March 2, 2022

    Report

    Report Number
    MW5107856
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    December 21, 2021
    Report Date
    December 21, 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 REPORTED NO DISPOSABLE PUMP WONT RUN ALARM ON BOTH PUMPS WHEN NEW CADD FLOW STOP CASSETTE ATTACHED, CASSETTE WASTED AND PATIENT MIXING NEW REMODULIN CASSETTE. LOT 4163625. EXPIRATION 07/15/2026, NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631629 LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.
    2631630 LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC.
    2631631 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4163625

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female