BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP

    MDR report key: 13808918 · Received March 17, 2022

    Report

    Report Number
    MW5108236
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    March 2, 2022
    Report Date
    March 2, 2022
    Manufacturer
    UNK
    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 NO DISPOSABLE ALARM ON BOTH PUMPS WHILE USING 100 ML CASSETTE WITH FLOWSTOP. LOT NUMBER 4196395, EXPIRATION DATE 2026-09-20. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548173 PUMP PUMP, INFUSION LHI UNK
    548174 PUMP PUMP, INFUSION LHI UNK
    548175 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4196396

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female