BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 13736353 · Received March 10, 2022

    Report

    Report Number
    MW5108071
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    January 11, 2022
    Report Date
    January 11, 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

    INBOUND. PATIENT¿S WIFE REPORTS PATIENT HAS HAD 6 CASSETTES THAT BECAME UNUSABLE WITH NO DISPOSABLE PUMP ALARMS AFTER BEING USED FOR SEVERAL HOURS. TROUBLESHOOTING DID NOT RESOLVE, AND A NEW CASSETTE HAD TO BE MIXED AND CHANGED EARLY EACH TIME. PATIENTS SON DISCARDED 3 CASSETTES, NOT KNOWING THEY NEEDED TO BE CALLED IN. THE THREE REMAINING CASSETTES ARE LOT NUMBERS 4146497 EXPIRATION DATE 2026-05-23, 4189440 EXPIRATION DATE 2026-09-04, AND 4189440 EXPIRATION DATE 2026-09-04, ISSUE TOOK PLACE BETWEEN (B)(6) 2022. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872305 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4146497
    1872306 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4189440
    1872307 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4189440
    1872308 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1872309 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.
    1872310 CADD CASSETTE 100ML W/FLOWSTOP SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC.