BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE

    MDR report key: 14194345 · Received April 22, 2022

    Report

    Report Number
    MW5109302
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    April 13, 2022
    Report Date
    April 13, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INBOUND. PATIENT REPORTS PARTIALLY USED 100 ML FLOW STOP CADD CASSETTE WITH 36.9 ML LEFT IN IT WAS RUNNING FINE, THEN STARTED BEEPING AND ALARMED NO DISPOSABLE. CASSETTE LOT NUMBER 4220003, EXPIRATION DATE 2026-11-24, TROUBLESHOOTING DIDN'T RESOLVE ALARM WITH PUMP 370324 AND IT ALARMED ON PUMP 362270 ALSO. CASSETTE WORKED ON PUMP 337937. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445361 CADD CASSETTE SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 370324 4220003
    1445362 PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 362270

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female