BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE 100ML W/FLOWSTOP

    MDR report key: 10628733 · Received October 2, 2020

    Report

    Report Number
    MW5097062
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 18, 2020
    Report Date
    September 18, 2020
    Manufacturer
    CADD / SMITHS MEDICAL
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INTERNAL PC ONLY. INBOUND. PATIENT REPORTS FREQUENT HIGH PRESSURE PUMP ALARM WHEN USED 6 CADD FLOW STOP CASSETTES FROM SAME LOT 3962244, NO FURTHER DETAILS PROVIDED; 6 CASSETTES FROM SAME LOT CAUSED HIGH PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082868 CADD CASSETTE 100ML W/FLOWSTOP PUMP, INFUSIONI, PCA MEA CADD / SMITHS MEDICAL 3962244

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR