BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13660259 · Received March 2, 2022

    Report

    Report Number
    MW5107849
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    December 8, 2021
    Report Date
    December 8, 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

    PREFILLED REMODULIN CASSETTE "#3" FROM (B)(6) 2021 SHIPMENT ALARMED WITH BEEPING, THEN NO DISPOSABLE ALARMS WHEN IT HAD RESERVOIR VOLUME SHOWING 81.8 ML, UNABLE TO GET IT TO WORK ON EITHER PUMP AND HAD TO WASTE IT. LOT NUMBER 2101977, EXPIRATION DATE OF 01/31/2023 NOTED ON SHIPMENT INFORMATION FOR THE REMODULIN IN IT. HAD TO USE A NEW PREFILLED CASSETTE WHEN TROUBLESHOOTING DID NOT RESOLVE ALARM. NO FURTHER DETAILS PROVIDED, RESOLVE ALARM, NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631617 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 2101977

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female