BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14428081 · Received May 18, 2022

    Report

    Report Number
    3012307300-2022-08959
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    January 6, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (1/2 REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING CASSETTE) PER MEDWATCH MW5108069: INBOUND. NO DISPOSABLE PUMP ALARM USING 100ML CASSETTE FROM LOT 4173645 EXPIRATION 08/19/2026. REPLACEMENT PUMP SENT. NO FURTHER DETAILS PROVIDED. MEDWATCH REPORT MW5108074 RECEIVED 20/APR/2022. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851190 CADD SET,ADMINISTRATION,INTRAVASCULAR FPA ST PAUL 21-7302-24 4173645 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown