BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 13455064 · Received February 4, 2022

    Report

    Report Number
    3012307300-2022-02579
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 17, 2022
    Report Date
    December 12, 2022
    Manufacturer
    NULL
    Product Code
    FPA
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES ARE NOT REQUIRED. NO PRODUCT WAS RETURNED THEREFORE, NO VISUAL OR FUNCTIONAL EVALUATION CAN BE PERFORMED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN AND CANNOT BE DETERMINED AS NO SAMPLE WAS RECEIVED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. NO LOT NUMBER WAS PROVIDED THEREFORE, A MANUFACTURING DEVICE HISTORY RECORD DHR REVIEW COULD NOT BE PERFORMED., CORRECTED DATA: CORRECTIONS IN: D1: BRAND NAME: UPDATED, D2: COMMON DEVICE NAME: UPDATED, PRODUCT CODE: FPA, G5: PREMARKET 510K: K081156.

    Description of Event or Problem · 0

    REFERENCE TO (B)(6) FOR RELATED COMPLAINTS (DOCUMENTING CASSETTE #3 USED WITH PUMP #3 WITH UNDER-DELIVERY). NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084711 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA
    586748 CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown